Azopharma Product Development Group has added microdosing and central lab services to its clinical pharmacology research facility, AvivoClin Clinical Services, in Daytona Beach, FL. The additional services will be accommodated by a recent facility expansion that began in March 2008.

Microdosing provides early pharmacokinetic and pharmcodynamic data in humans for pharmaceutical and regulatory agencies. AvivoClin now offers Phase 0 microdosing services that include synthesis and labeling of material, formulation, administration of microdoses, and analysis of samples.

AvivoClin will also offer central lab services in an effort to provide quicker turn-around time for results, a decrease in errors, and a reduction in costs. According to Phil Meeks, chief executive officer of Azopharma, “The increased space and capabilities allow us to better serve the growing needs of our clients. Through AvivoClin, Azopharma Product Development Group can support numerous clinical studies simultaneously resulting in higher level of service.”

Cetero Research Expands Phase I Capabilities

Cetero Research has expanded its San Antonio operations with a new purpose-built, 100-bed facility designed to run clinical pharmacology studies in healthy, diabetic and obese participants. The new facility consolidates its operations into a single four-story building.

“The site has conducted clinical studies for more than 25 years. We are excited that this new building further expands our capabilities and capacity for clinical research. One notable expansion is increased capacity to perform euglycemic and insulin-clamp studies,” said Dr. Sherwyn Schwartz, chief executive officer of Cetero’s San Antonio facility. “These specialized studies are ideal for establishing proof-of-concept for novel compounds, or even comparing compounds to show superiority or equivalence.”

“Our staff is very excited about working under one roof in the new facility. The building was designed to house healthy and patient populations participating in first-in-human and proof-of-concept studies, as well as very complex euglycemic and insulin-clamp studies,” said Dr. Robert Earl, president of Cetero’s San Antonio facility. “San Antonio’s highly-respected principal investigators, nurses and study managers have many years of experience running Phase I to Phase IV studies for biotechnology, device and pharmaceutical companies.”

The facility is located on the Christus Santa Rosa Medical Campus and provides access to Type I and Type II diabetics and obese patients, as well as patients with hypogonadism, neuropathy, osteoporosis and erectile dysfunction.

Univ. of Arizona Opens Laboratory for Emerging Contaminants, UA

The Arizona Laboratory for Emerging Contaminants (ALEC) at The University of Arizona will opened Jan. 21, 2009.

Emerging contaminants are potentially toxic substances whose presence in the food or water supply is poorly known, and whose health effects also are often poorly known.

Some better-known emerging contaminants include pharmaceuticals such as estrogen, Viagra and Prozac, and chemicals such as bisphenol A, a compound found in certain plastics.

"ALEC is focused on detection and quantification of inorganic and organic contaminants – inorganics such as arsenic, uranium and lead and organics such as endocrine-disrupting compounds, pharmaceuticals and personal-care products," says Jon Chorover, co-director of ALEC.

ALEC and its state-of-the art analytical equipment is available for use by anyone in Arizona's water research community. In addition, training students and future researchers is one of the lab's core missions, says ALEC co-director John Chesley.

"This is the only lab like it in the state of Arizona. Some of these compounds haven't been on anyone's radar until the last five to 10 years," Chesley continues.

There is increasing concern worldwide that even trace amounts of such contaminants can harm human health and also that of agricultural and other ecosystems. ALEC's equipment can detect such contaminants at much lower concentrations than was previously possible.

Emerging contaminants in water are a particularly significant problem in Arizona and other arid and semi-arid regions.

"It's important to understand that anything that interacts with water is a potential source of water contamination," says Chorover.

In many parts of Arizona, treated wastewater is used to recharge the groundwater, biosolids from treated waste are added to agricultural soils, and reclaimed wastewater is used for irrigation.

Colorado River water, which supplies water to Arizona cities, towns and farms, contains an array of trace contaminants.

ALEC will also work with researchers who study how persistent pollutants like the solvent trichloroethylene, or TCE, behave in the environment, Chorover says.

ALEC is a collaborative effort involving faculty from the UA Colleges of Science, Agriculture and Life Sciences, Engineering and Pharmacy, and researchers from Arizona State University in Tempe and Northern Arizona University in Flagstaff.

Non-profit R&D Battelle Investing $200m in Its Facilities in Ohio

The Battelle Memorial Foundation, which says it is the world's largest nonprofit research and development organization, announced plans for a $200 million series of projects that include the modernization and renovation of its Columbus, Ohio, offices, as well as other facilities in two nearby Central Ohio communities.

Battelle said it would renovate its offices and laboratories at its King Avenue campus, in part by incorporating energy-efficient technologies suitable for certification under the Leadership in Energy and Environmental Design building standards developed by the US Green Building Council. That work, Battelle said, would enable it to create more than 200 new science and research jobs.

Also in Columbus, Battelle is expanding and upgrading its biomedical research facilities to strengthen its safety and efficacy evaluation capabilities for clients in the pharmaceutical and biotechnology industries, and well as the food sector. The foundation will build a new, 16,000-square foot Battelle Discovery Center, a day care and early education center for children of employees.

In West Jefferson, Ohio, Battelle will construct a new health and life sciences research laboratory slated for operation in 2011. Battelle said the new facility would further expand its capabilities in biomedical research and development.

In Dublin, Ohio, Battelle said it plans to renew the lease and expand capabilities at its Blazer Parkway production facility to boost light manufacturing capacity and increase production of key electronic components used by medical customers and the U.S. military.

Battelle last year opened a new armor assembly facility in West Columbus, Ohio.

Jeff Wadsworth, CEO of Battelle, said: “We are making these investments now to continue to advance science and accelerate our development of innovative products, services and solutions in the areas of energy, national security, and the health and life sciences. We are pleased to share our growth with Ohio by investing in the region and creating jobs.”

Ohio has been badly hit by the economic climate, with reports claiming job losses are occurring at a greater rate than any time since the great depression, and consequently Battelle’s investment has been well received in the state.

Battelle is predicting that its investment will create 200 science and research jobs and generate an economic output of $450m over the course of the construction.

Ohio Governor Ted Strickland said: “Critical to the success of the Ohio economy is our continued support of organizations like Battelle, which foster innovation and research as well as create the jobs that will lead us through the 21st Century.”

Contract Research Firm Covance Will Open a $100m (€77m) Animal Testing and Drug Development Facility in Chandler, Arizona, US.

The 77-acre site, which will be opening in March, will be used to test drugs on mice, rats, dogs and monkeys. Covance may expand the facility and add a human clinical trials centre in due course.

Covance has previously stated that the facility, construction of which began in 2007, will help it meet the demands of its drug development clients on the west coast of the U.S.

Perhaps predictably there has been considerable objection to the facility from animal rights groups who question the need for animal testing. In 2006, 15 activists picketed Covance in protest about the plant according to a report in the Arizona Republic newspaper.

However, others including Ray Woosley, CEO of the non-profit pharmaceuticals regulatory group the Critical Path Institute, have defended Covance and welcomed the new facility as a beneficial addition to the State's economy.

He told the newspaper that: "If anyone objectively looks at Covance, that's the kind of partner you want in a community because they do [toxicology testing] right," adding that "there are some forms of toxicity that you won't know about until you give [the drug] to a living animal."

Covance says the new facility will employ around 600 people, of which, 80 have already been hired. At present the firm has six non-clinical development facilities at sites in the UK, Germany and the US and employs about 3,200 testing staff worldwide.

UC Berkeley Slowing Construction of Phase 2 Li Ka Shing Center for Biomedical and Health Sciences

The University of California, Berkeley, is slowing construction of the 200,000-square-foot building that comprises the second phase of the Li Ka Shing Center for Biomedical and Health Sciences, because the school is unsure how much funding it will receive toward construction of the facility from the state, the San Francisco Chronicle reported.

Nathan Brostrom, the school's vice chancellor for administration, told the Chronicle that UC is expecting a budget cut of about $45 million from the $500 million it usually receives from the state.

Med Device Marketer Emerges as Frontrunner Among Would-be Tenants for Surprise, Ariz., City Hall

A company that markets medical devices is the front-runner among three would-be tenants interested in leasing the City Hall building to be vacated by the city of Surprise, Ariz., when it moves to a new municipal facility this summer, the Arizona Republic reported.

City Manager Randy Oliver is in talks with the firm and could finalize an agreement soon; a deal could be announced as early as February. The med device marketer, whose identity is not being disclosed by city officials, was among three respondents to a formal request for proposals for reusing the 58,000-square-foot building, at 12425 W. Bell Road. Respondents were limited to biotech and pharmaceutical production companies that the city believes will create high-wage jobs.

The city has no plans to sell the building, which is valued at more than $8.6 million. Also ruled out by the city are plans to return the building to retail use. Before it became City Hall, the building was a shopping center that included restaurants and a beauty salon.

NC Biotechnology Center Eyes Laboratory Use for Former Elizabeth City Middle School

A committee of the Pasquotank County Board of Commissioners has agreed to gather details and costs on a wide variety of options for redeveloping the former Elizabeth City Middle School building — including a plan to turn the facility into a laboratory building.

Wayne Harris, director of the Albemarle Economic Development Commission, said the Eastern North Carolina office of the state-funded North Carolina Biotechnology Center was interested in using the facility for laboratory space. Representatives from the center plan to examine the building's interior in January.

Another option: Convert the former school to a teaching clinic for the East Carolina University School of Dentistry. County Manager Randy Keaton, who favors the dental clinic option, and county Commissioner Lloyd Griffin noted that the nearby College of The Albemarle also could offer a dental hygienist program in the building. Griffin said in keeping with the former school's past use, he hoped to keep job training and work force development as part of the building's future use.

The committee asked county staff to develop estimates for demolition of the school.

German Maker of Biotech Robotics Opens US Offices in Cheyenne, WY

Vulkan Technic Maschinen-Konstruktion, a German manufacturer of customized robotics for the biotechnology, automotive, glass, food, and beverage industries, has signed agreements with the private nonprofit Cheyenne (Wyo.)-Laramie County Corporation for Economic Development, also known as Cheyenne LEADS, to open its first North American plant in Cheyenne.

Vulkan is expected to employ 10 people by the end of 2009, and more in the future. Cheyenne LEADS began discussions with Vulkan after responding to a request for information through the Wyoming Business Council. Vulkan toured several Wyoming communities with the WBC last July, before selecting Cheyenne.

Gregor Trierscheid, Vulkan's manager for North American operations, said the company sought to locate near the University of Wyoming and Denver International Airport. Edgar Caspers, managing director of Vulkan Technic, told the Casper (Wyo.) Star-Tribune says he hopes to build a relationship with the university that's similar to the company's relationship with Germany's University of Pforzheim.

Founded in 1995, Vulkan has its global headquarters in Wiesbaum, Germany, one hour south of Cologne.

Seller of Used Lab Equipment, Asset Management Services, Opens New Fremont, Calif., Site

BioSurplus, a San Diego seller of used laboratory equipment and asset management services for the life science industry, has opened a new 10,000-square-foot facility in Fremont, Calif., that includes a showroom. BioSurplus has also added to its staff three people to manage the new facility and support Northern California customers.

Biotech Startup Plans Expansion Move to Cocoa, Fla., Following $12K Tax Exemption,Tax Credits from Brevard County

Biomedical startup GeNO has been approved by the Brevard County Commission for up to $73,945 in tax credits toward a move to Grissom Ridge Commerce Park in Cocoa, Fla., where it plans to create 12 jobs, according to Florida Today of Melbourne, Fla. The new Cocoa facility is a $1.1 million, 6,000-square-foot space on Oxbow Circle that is expected to open in April. A second building on Oxbow Circle will be built later on when the company advances toward drug production.

GeNO, which now employs six people, will receive county tax credits over 10 years if it creates the new jobs in the next 18 months with annual salaries of $80,000. In addition to county tax credits, GeNO will also receive a 60 percent tax exemption over three years from Cocoa, projected to save the company $12,000; and a 50 percent waiver of the cost for building permits and water and sewer fees.

GeNO may also hire an additional 10 people, the company's president and chemist David Fine told the newspaper.

GeNO focuses on making drugs and devices involving nitric oxide to treat medical conditions such as pulmonary edema, pulmonary hypertension, altitude sickness, and chronic obstructive pulmonary disease, or COPD. One key challenge is confining the gas, typically administered from large tanks, into smaller, portable containers.

Fine is a cofounder of Orlando-based CyTerra, a supplier of mine-sweeping and bomb-detection devices used in Iraq and Afghanistan that was sold in 2006 to L3 Communications for an undisclosed sum.

GeNO is one of at least a dozen biotech companies and research institutes that have taken root on the Space Coast in recent years, many of them in Titusville and southern Brevard, Florida Today reported.

Vertex Renews Leases for 292K Sq. Ft. of Existing Space in Two Cambridge, Mass., Buildings

Vertex Pharmaceuticals will not fulfill its goal of consolidating all employees at a single facility until at least 2015, as the Cambridge, Mass., drug discoverer signed renewal leases expiring that year for a combined 292,000 square feet at two buildings it occupies in the city.

Vertex will continue to lease 192,000 square feet at 200 Sidney St., as well as its 100,000-square-foot headquarters at 130 Waverly St., from the owner of both buildings, BioMed Realty Trust. The San Diego-based publicly-traded real estate investment trust announced the lease renewals on Jan. 15, in a press release that trumpeted the REIT's "proactive approach to leasing and renewals" — namely pursuing the renewal of the Cambridge leases more than a year before they were set to expire.

Vertex leases a combined 600,000 square feet at its Cambridge buildings, where it occupies a combined 500,000 square feet; the remaining 100,000 square feet, all at 675 W. Kendall Square, is subleased to Genzyme and Momenta Pharmaceuticals.

Vertex spokesman Zach Barber would not discuss what commercial real estate professionals have speculated was a key factor in the renewals — the collapse of a lease deal trumpeted last summer in Boston-area newspapers. The deal, which Vertex never confirmed, would have consolidated Vertex operations within 500,000 square feet at Fan Pier, a development planned for the South Boston waterfront by local developer Joseph Fallon.

But by November, after Fallon struggled to raise financing for Fan Pier due to the economic upheaval, one local newspaper report had Vertex in talks for renewing some 300,000 square feet of space in Cambridge.

"We always said that staying in Cambridge was an option. What the lease extensions do is give us the flexibility now to continue looking at other options where we can consolidate our employees into one location, and we'll do that over the next several years. Ultimately, our goal is to consolidate the employee base into one location," Barber said. "We'll spend the next several years looking at other options in the Greater Boston area for expansion and consolidation."

Vertex leases approximately 685,000 square feet at five BioMed properties, including approximately 604,000 total square feet in Cambridge and 81,000 square feet in San Diego.

Choose Worcester (Mass.), Grafton Science Park Operator Pursue Biomanufacturer Seeking Site through MAED

One local organization and another development group have responded to a request for proposals issued by the Massachusetts Alliance for Economic Development on behalf of an undisclosed company that contacted the private, nonprofit group, seeking sites in the Bay State where it can establish a 650,000-square-foot manufacturing plant for biopharmaceutical research and development, including in vivo animal testing, the Worcester Business Journal reported.

Choose Worcester, a nonprofit organization that promotes economic development in the city, responded to the request by pitching a site near the Worcester Regional Airport. Also responding was the company that runs the Grafton Science Park for Tufts University's Cummings School of Veterinary Medicine, the newspaper reported.

According to the RFP, the site must be able to provide 12,500 therms of natural gas a month and the average daily water use is 20,000 liters and its waste discharge is estimated to be 10,000 pounds a month. The building needs to be between 60 and 90 feet high. It must be a flat site and be zoned for bio-manufacturing.

Lonza Bioscience Plans $26 Million Building, 80 New Jobs in Walkersville, MD

A growing market for its cell therapy program has allowed Lonza Bioscience to expand its Walkersville, Md., site with a $26 million new building and 80 new staffers, the Frederick (Md.) News-Post reported.

The new 44,000-square-foot building will house three Class 10,000 cell production sites and office space. The building will be linked to the existing warehouse at Lonza with a two-level connector.

Lonza began planning for the new building in 2007, the year it acquired the bioscience division of Cambrex. The Biggs Ford Road site was initially opened as BioWhittaker, but was later acquired by Cambrex. Lonza acquired Cambrex's division in 2007 for $460 million.

About 450 people are employed at the site, in cell-based research, endotoxin detection and cell therapy manufacturing positions, the News-Post reported.

Completion of the new building is expected in fall 2009. The design team for the new building includes Baltimore-based architects ArchTech Design, and Kensington, Md.-based mechanical engineering firm Encon Group, which together have worked on more than 20 different projects at the 11-acre Lonza Walkersville site.

Calif. BioCenter Expansion to Start in Spring; $5 Million Biomanufacturing Center to Rise

A public-private life-sciences incubator in San Jose, Calif., will start work this spring on an expansion that will take a year to complete and cost $10 million over five years and nearly double its existing footprint, and develop a $5 million biomanufacturing center for startups looking to produce their own therapies.

The San Jose BioCenter will expand into 33,750 square feet on the first floor of 5941 Optical Court. The incubator currently occupies 36,594 square feet on the building's second floor.

BioCenter CEO Melinda Richter told BRN last week that three on-site life-science companies — Tacere, Aridis, and Devro Medical — will move from the incubator's second floor to portions of the first-floor space.

Expansion work will follow after the San Jose Redevelopment Agency finalizes construction documents and issues a formal request for proposals for general contractors, Julie Amato, SJRA's senior development officer managing the BioCenter expansion project, told BioRegion News earlier this month.

"At this point, we would anticipate probably beginning construction at some time in the spring of this year, and then finishing probably about a year from now, [in] January 2010," Amato said.

Amato and Abi Maghamfar, the agency's deputy executive director, spoke with BRN three weeks after the SJRA's board cut $500,000 from the $2.5 million it had set aside from its original capital budget for the fiscal year ending June 30.

Last month, citing the weak global economy, the SJRA trimmed its previously approved five-year budget into a two-year, $259 million spending plan that retained the BioCenter expansion, albeit with the half-million-dollar cut.

That cut, Maghamfar said, will not affect the planned expansion, because the board last month also approved a new five-year, $1.1 billion capital-improvement program that authorized $10 million for construction and tenant improvements to the new first floor space — including the $4 million that has already been set aside in the agency's new two-year capital budget.

The agency plans to "close the gap with the other $6 million in different type of financing until other further budgeting actions are taken," Maghamfar said.

The SJRA, he said, plans to spread its costs by financing part of that outlay. A precedent for that exists: Mission West Properties of Cupertino, Calif., the owner of the building that houses the BioCenter, and the Edenvale Technology Park where the building is located, helped finance part of the development of the original bio incubator five years ago.

"Whether that methodology will be used as a part of this expansion is still in the works. We have no confirmation on that as of yet," Maghamfar said.

He said SJRA and Mission West are in "ongoing negotiations" in part over how to pay for cost overruns beyond the $10 million. "Like any other construction on a brand-new building, the landlord generally puts in some tenant improvement allowance," Maghamfar said. "There may be some additional funding coming in that respect, but nothing beyond that."

While acknowledging the ongoing global financial upheaval has made it more difficult to obtain capital, Maghamfar said the agency's relatively favorable bond ratings should allow it to obtain the financing it needs over the next few years.

"We are not concerned at all that we'd be able to secure proper financing here," he said.

Yet one bond rating agency, Fitch Ratings, has questioned whether the technology sector will remain strong enough over the next several years to advance the BioCenter expansion and all other projects planned for the city's 21 redevelopment areas totaling more than 8,000 acres — including the Edenvale Redevelopment Project Area that includes the 2,312-acre Edenvale Technology Park, where the BioCenter sits.

Last October, Fitch downgraded from A to A-minus its rating on the 2008A series of San Jose's tax-allocation bonds for the 21 redevelopment areas, known collectively as the Merged Area Redevelopment Project, in advance of the city's Dec. 3 sale of $37.2 million of TABs.

The downgrade "reflected the relatively narrow debt service coverage following the new issuance, coupled with the negative macroeconomic environment that is likely to pressure assessed value of major taxpayers, and particularly unsecured property in the technology sector that dominates the Merged Area Redevelopment Project," Fitch said in a statement.

"Historically, the project area's unsecured personal property has been vulnerable to significant declines during economic downturns and may be subject to declines in the coming years in light of the current economic environment," Fitch added.

Said Maghamfar: "We are very comfortable and confident that our financing strategy is sound and that we'd be able to move forward."

In approving funding for the BioCenter expansion, Maghamfar said, the SJRA was fulfilling one of its goals and objectives listed in the 2008-09 spending plan: "Provide ongoing support" for the biotech incubator and three other city-funded incubators: the US Market Access Center, the former International Business Incubator that assists overseas-based life-sciences and other tech companies seeking to crack the American market; the Software Business Cluster; and the Environmental Business Cluster, which nurtures businesses in the cleantech sector, another priority of San Jose officials.

Opened in 2004, the BioCenter has 22 onsite resident companies and 15 "affiliate" companies that use the incubator's equipment for a fee.

According to BioCenter's Richter, the three life-sci companies scheduled to move from the incubator's second floor to portions of the first-floor space are:

Tacere, a developer of therapeutics for treating hepatitis C and other diseases. The company has a $145 million collaboration and licensing agreement with Pfizer, and a $60 million deal with Oncolys Pharmaceuticals for the HCV compound.
Aridis, a developer of dried biologicals administered in ready-to-use formats against pediatric infectious diseases. Its clinical-stage product candidates include Panaecin, used for treating lung, skin, and mucosal bacterial infections; and Aerucin, a human monoclonal antibody designed to protect against chronic lung infections by the pathogen Pseudomonas aeruginosa.
Devro Medical, a Scottish-based supplier of Australian purified collagen formulations seeking to expand in the US.

Richter said the BioCenter and SJRA work with incubator companies about to outgrow their spaces to help them relocate elsewhere in San Jose.

Local Capacity Shortage

Maghamfar also told BRN that the redevelopment agency and BioCenter this year will also pursue plans to build a new biomanufacturing center within the Edenvale Redevelopment Area.

"We are in the process of working on an RFP to solicit interest from interested biomanufacturing companies, probably in the next five to six months," Maghamfar said. "We're hoping to get some responses and conclusion by summertime."

Even before the formal proposal request is issued, at least two key decisions have been made on the project: The redevelopment agency board last month budgeted $5 million in its 2009-10 spending plan for the planned biomanufacturing center, while SJRA has ruled out building the biomanufacturing facility within the BioCenter's first-floor expansion space. However, it still hopes to find a site near the BioCenter, according to Maghamfar.

Added Amato: "The reason there was never any intention to put that in the BioCenter expansion was simply because we were anticipating that the manufacturing facility would be larger than the expansion."

Maghamfar added: "We strongly believe that the Edenvale technology park would be the most suitable and ideal location. But then again we haven't crossed those discussions yet."

Other key questions about the project remain unanswered, such as where the center should be built, how much space it should contain, and what businesses would use it.

Planning for the biomanufacturing center comes six months after a consultant hired by the SJRA submitted to the agency board a $205,000 study recommending development of such a facility. PharmaBioSource of Wayne, Pa., estimated that a biomanufacturing center would contain 25,000 square feet of space, and would cost up to $23 million to build new, or up to $16 million if an existing building were retrofitted, in addition to the $8 million it would cost to equip the facility.

The 31-page report said that while the West Coast has the highest concentration of biotech firms in the nation, only 16 contract manufacturing organizations in the region can produce the drugs those companies have developed in market quantities — a market gap on which the BioCenter could capitalize.

"The lack of CMO production capacity today in the Western region coupled with the lack of plans for future capacity in the region indicate that this local capacity shortage will continue," the report observes. "As a result, many Western companies are forced to use biological CMOs outside the Western region, mainly in the Eastern U.S. and Europe."

For its report, PharmaBioSource said it interviewed 25 West Coast biotechnology companies, of which 10 occupy space at the San Jose BioCenter. While the companies interviewed prefer to outsource their manufacturing, "Western regional companies are generally dissatisfied with the availability of qualified CMOs that they can afford," the report said. "They are also frustrated at not having the choice of a local CMO that can provide the required range of services.

"Furthermore, as smaller firms, they do not receive the attention of most CMOs," the report added. "They are eager to have access to a local CMO that brings a strong track record and manufacturing experience to the Bay Area."

The report recommended that the biomanufacturing center and surrounding land be owned by a developer that leases the facility to a CMO partner that would own the equipment, employ staff, and oversee all manufacturing and regulatory operations — with no direct involvement by the SJRA. The center would be a cGMP facility capable of producing drugs for human clinical trials, using both mammalian cell culture and microbial fermentation manufacturing systems.

"Annual revenues are estimated at $11 million to $13 million, with 10 percent to 20 percent in profit margins. This facility option has the highest revenue and profit potential. As a result, this option would likely attract interest from the greatest number and types (e.g., large and mid-tier) of CMO partners," the report concluded.

Swiss Novartis to Receive $487 Million (€366m) from the US HHS for its Cell-Culture Flu Vaccine Plant in Holly Springs, NC

The facility, which will boost US vaccine production 25 per cent when fully operational in 2012, has been under construction since 2007 when Novartis won its original Department of Health and Human Services (HHS) contract.

The U.S. Department of Health and Human Services granted the eight-year contract to build and run a vaccine manufacturing site in Holly Springs, North Carolina, Novartis said.

The company said more than 300 people will be employed there by 2012. The plant will be used to develop a new flu vaccine using cell cultures. Existing vaccines are derived from eggs and can take up to nine months to produce.

The plant will serve a double function, producing vaccine to inoculate people from seasonal flu and adding to U.S. government preparedness against an influenza pandemic. In that event, the plant would aim to produce 150 million doses of vaccine within six months.

The new deal calls for Novartis to develop two new vaccines, for either seasonal or pandemic use, and provides funding for clinical bridging studies designed to compare the firm’s vaccines to existing products in terms of safety and efficacy, potentially expediting their approval by the US Food and Drug Administration.

As Robin Robinson of the HHS’ Biomedical Advanced Research and Development Authority (BARDA) said, the plant and the flexibility it provides are vital to the country’s pandemic plans.

“In a pandemic we would need vaccine ready within six months,” Robinson explained, adding that this goal could not be accomplished using traditional egg-based manufacturing methods.

Andrin Oswald, CEO of Novartis Vaccines and Diagnostics commented that: "The site will provide jobs for more than 300 highly skilled people with the capability to produce cell-based seasonal flu vaccine, pre-pandemic vaccine and 150m doses of pandemic vaccine within six months of the declaration of an influenza pandemic."

The ability to freeze cell cultures means that they can be made available for large scale production in a fraction of the time taken to procure the millions of hens eggs needed to make vaccine using the traditional approach, significantly reducing manufacturing lag.

Such flexibility and speed means production can be delayed until the specific virus strain responsible for an epidemic, or pandemic, has been properly identified. This avoids the best -guess, blanket approach of combining several likely strains in a vaccine that is necessitated by the longer manufacturing times needed for egg-based production.

Novartis is at the forefront of cell-culture vaccines through its partnership with Dutch firm Crucell and access to the latter’s popular PER.C6 cell line. In 2007, Novartis’ Optaflu, production of which is due to be switched from the firm’s plant in Marburg, Germany to Holly Springs, became the first cell culture-derived vaccine to be cleared by European regulators.

Joerg Reinhardt, Novartis COO said: "We believe that this contract award underscores the US Government's commitment to ensure pandemic vaccine supply, and reflects their confidence in Novartis.”

The announcement of the new contract coincides with the release of a HHS report highlighting “major gaps” in the country’s strategy for coping with the predicted influenza pandemic.

The authors said that although progress has been made, the protection of government workers as a way of maintaining vital infrastructure was not being given sufficient thought, commenting that “even the best plans can fail if managers cannot accommodate significant absenteeism.”

GSK’s Plant in Pennsylvania, US Hopes to Become Global Hub of Its Vaccine Packaging and Filling Business.

Operations at the 650,000 sq ft Marietta plant, which are due to begin in April, will initially focus on GlaxoSmithKline’s (GSK) Energix B hepatitis B vaccine subject to approval by the US Food and Drug Administration (FDA).

Specifically, the facility will receive shipments of filled Energix B syringes from GSK’s plant in Rixensart, Belgium to which plunger rods and laser printed labels will be added in a fully automated process, before final packaging takes place.

GSK bought the Marietta site in 2005 for $14m from US drug major Wyeth, which had been struggling to maintain it as a going concern and downsizing its workforce since 2002.

Having completed the acquisition, GSK set about spending more than $300m to transform the plant into a state of the art development, production and packaging campus complete with sophisticated freeze-drying technology.

The facility forms the centrepiece of GSK’s plans for its vaccines business which, at present, includes products like the anti-rotavirus agent Rotarix and Fluarix for seasonal influenza and generates around $4bn a year.

Other steps in GSK’s expansion plans include gaining US clearance for its cervical cancer vaccine Cervarix and a near doubling its portfolio of approved products, to 21 vaccines, over the next four to five years.

By 2010 when the plant is expected to be fully operational with a workforce of 250 employees, GSK will begin production operations focusing on the aseptic preparation of viral antigens, vaccine formulation and freeze drying.

The UK based drug major plans to make mumps, measles, rubella and varicella vaccines as well as several of the pediatric vaccine candidates in its pipeline, should they go on to receive US approval.

The unit is also intended to provide rapid-response production capacity for influenza virus vaccine, using the cell culture methods that it gained through the purchase of former development partner Corixa in 2005.

Robinson Pharma Inc (RPI), a Dietary Supplement Contract Manufacturer, said Its Latest Quality Audit has Confirmed Continued cGMP Compliant Operations

The audit, performed by Specialized Technology Resources (STR), grants the company continued certification under the Retail Qualification Program (RQP). These standards were originally established to assure the safety, purity and label claim compliance of supplements sold in a major national retail chain.

According to Robinson Pharma’s vice president of marketing Kenn Israel, the firm’s investment in quality has already allowed it to expand into the private label market.

“Partnering with STR, along with other key strategic initiatives, has facilitated the transformation of RPI from a contract manufacturer to a competitive private label supplier of some of the leading marketers of dietary supplements in the United States and other international markets,” he said.

The STR audit – which confirms the purity, safety and labeling of products – tested Robinson Pharma’s standard operation procedures, staff qualifications and staff training program. It also evaluated facility adequacy and cleanliness.

Aspects of the manufacturing process that were reviewed include receipt and authentication of ingredients, the production process, post production product analysis, product handling, packaging, storage, and record keeping, said RPI.

Certified quality standards are now becoming indispensible in all levels of the supplement manufacturing industry after the introduction of new quality regulations last year.

FDA’s good manufacturing practices (cGMPs) for supplements, designed to ensure quality, safety and consistency, have already been adopted by large manufacturers in the US (over 500 employees). Mid-size companies are expected to comply by June this year, while small firms (less than 20 employees) have until June 2010 to comply.

Robinson Pharma, which can produce 12bn soft gel capsules per year, said it has made “significant investments” in manufacturing systems that ensure constant monitoring of all aspects of its production process.

It said it has designed systems for ingredient receipt and testing, pharmacy and pre-production processing, manufacturing, post production testing and packaging.

Much of this work was conducted in partnership with STR, which RPI said provided “guidance and objective perspective” on its progress and execution

Biotechnology Company Cel-Sci is Hoping to Offer Contract Manufacturing in Baltimore

US biotechnology company Cel-Sci is hoping to offer contract manufacturing to pharmaceutical partners from its new facility in Baltimore, as it tries to raise money to support the clinical development of its cancer immunotherapy Multikine.

The company has won US approval to start a Phase III trial of Multikine, a mixture of naturally-derived cytokines, in advanced primary (previously untreated) head and neck cancer patients.

Cel-Sci needs to raise funds via a financing or partnership before it can move ahead with the clinical program, and is having to cut costs to save cash. Raising money “by offering contract manufacturing services to the pharmaceutical industry in its new manufacturing facility” is one approach under consideration.

At the moment the company is burning through its cash reserves, spending just over $4m on R&D in the year ended September 30, 2008, and is largely dependent upon the proceeds from the sale of its securities to meet all its liquidity and capital resource requirements.

The company said it will operate at “significantly reduced cash expenditure levels” for the time being, which will allow it to eke out its reserves through January 2010.

In October 2008, Cel-Sci took delivery of a 73,000-sq. ft. manufacturing facility in Baltimore that has been refitted to produce clinical and future commercial supplies of Multikine at a cost of around $2.4m. That plant will cost the firm around $1.5m a year to lease.

While many small biotech operations choose to outsource manufacturing rather than build their own facility, Cel-Sci’s view has been that it is preferable to maintain close control of manufacturing processes.

“Good and consistent manufacturing and process control is critical and is best assured if the product is manufactured and controlled in the manufacturer's own facility by its own specially trained personnel,” said the company.

It is also keen to use the same facility to make clinical supplies as well as commercial batches – something that is preferred by regulatory authorities.

As of December 31, 2008, the biotech had 30 employees. Nine employees are involved in administration and 21 employees are involved in manufacturing.

U.S. Contract Manufacturer Ash Stevens Inc Upgraded Its Active Pharmaceutical Ingredient (API) Facility in Riverview, Michigan

Ash Stevens said it would use new equipment in its process development activities in order to accelerate the time it takes to scale-up a synthesis from laboratory conditions to the manufacturing level.

"These investments allow us to rapidly optimize chemical processes and better understand process safety parameters prior to scale up," said Dr. Stephen Munk, president and CEO of Ash Stevens. The company has been manufacturing APIs since the 1960s, and has developed specialist expertise in high-potency APIs (HPAPI), including cancer drugs.

The combined use of parallel synthesis with calorimetry instrumentation means that more reactions – spanning a broader range of conditions. The system captures real-time data and provides electronic records useful for post-experiment analysis and safety enhancements include the addition of a Thermal Screening Unit used to evaluate the onset of thermal decomposition of reaction components.

Traditionally, an experienced scientist could conduct two concurrent experiments manually in the laboratory, said the company. With the new system, up to four experiments can be conducted simultaneously, said Ash Stevens. "Our customers will benefit from increased time savings," added Munk.

The company said it also intends to bring a new three-reactor processing suite designed for carrying out hydrogenation reactions online in the third quarter of this year. The new suite will include a 50-gallon glass-lined steel hydrogenation reaction vessel as well as house a pair of 100-gallon vessels.

Ash Stevens said it intended to expand manufacturing at Riverview by 20 per cent out to 2010, with an increase in HPAPI capacity as well as this new plant-scale hydrogenation equipment.

Earlier in the year the company added new nuclear magnetic resonance (NMR) instrumentation for chemical and structural analysis, and glove box filter units for HPAPI handling.

Mt. Sinai Spinout Vivaldi Biosciences Nets $23 Million in Startup Financing

Influenza vaccine developer Vivaldi Biosciences, a spinout of the Mount Sinai School of Medicine in New York, said it has received commitments for $23 million in Series A financing, of which $18.85 million has been funded.

Bay City Capital and NGN Capital co-led the financing, with participation by the New York City Investment Fund and Alexandria Real Estate Equities. The remaining commitments are to be funded subject to achievement of certain milestones, Vivaldi said.

Vivaldi is developing vaccines with the potential for increased effectiveness in preventing seasonal and pandemic flu. The vaccines are based on research by Mount Sinai's Peter Palese and Adolfo Garcia-Sastre.

Elliott Kieff of Brigham and Women's Hospital, Harvard Medical School, will chair the company's scientific advisory board.

Vivaldi said that it intends to use the proceeds from its Series A financing to establish cell-based manufacturing and to file an investigational new drug application to advance its lead vaccine candidate to clinical trials.

SRI International Signs Licensing and Research Pact with AuricX Pharma

Non-profit research and development organization SRI International announced a licensing and research agreement with AuricX Pharmaceuticals.

Under the terms of the agreement, AuricX has gained rights from SRI to oral formulations of the antibiotic vancomycin. In exchange, SRI received undisclosed upfront payments and will be eligible for success-based milestones and royalties on sales.

Additional terms were not disclosed.

Early proof-of-concept work at SRI to develop the orally bioavailable vancomycin formulation was funded by a contract from the National Institute of Allergy and Infectious Diseases. Under the research agreement with AuricX, SRI will complete its formulation studies and fully optimize the oral bioavailability of vancomycin, the organization said.

U of Iowa Research Park Opens Incubator for Biotech Startups

The University of Iowa Research Park has opened its BioVentures Center, a business incubator that will house startup companies commercializing UI biotechnology research, as well as life science ventures wanting to locate near the university and use its research capabilities.

The 35,000-square-foot facility provides 20 wet laboratories and 16 offices for startup and early-stage biotech companies. The center is the largest wet-lab business incubator in Iowa and is the first major wet-lab space for startup companies to open at UI, Thomas Sharpe, associate vice president for economic development at UI, said in a statement.

The $8.5 million cost of the BioVentures Center was supported in part by Grow Iowa Values funds from the state and tax increment funding from the city of Coralville, where the center is located.

As of Jan. 8, more than 50 percent of the space was leased or committed. ASL Analytical, Cellular Engineering Technologies, Exemplar Genetics, KemPharm, Terpenoid Therapeutics, and Vertex Pharmaceuticals are the first companies slated to occupy the facility.

Burnham Institute and J&J Collaborate on Assay Development

Burnham Institute for Medical Research has signed an assay development and license agreement with Johnson & Johnson Pharmaceutical Research and Development.

The partnership is Burnham's first with a large pharmaceutical company, the institute said.

Under the agreement, Burnham will provide J&JRPD with access to high-throughput assay screening technologies to investigate certain drug targets for inflammatory diseases.

Financial terms of the agreement were not disclosed.

Copernicus Partners with U of Kentucky on DNA Nanoparticle Parkinson's Rx

Copernicus Therapeutics said that it will collaborate with the University of Kentucky to develop a DNA nanoparticle therapy for Parkinson's disease.

The collaboration is based on positive initial treatments in a rat model of Parkinson's disease conducted by UK researcher David Yurek.

Copernicus and UK will now conduct a second phase of studies to optimize the nanoparticle payload, a DNA expression system that may be capable of expressing candidate therapeutics for months or years in the affected brain regions of Parkinson's disease patients, Copernicus said.

Funding for the project has been provided by the Michael J Fox Foundation for Parkinson's Research. Copernicus did not disclose the funding amount or additional details of the collaboration.

Online Data Services Unveils Free IP-Exchange Website

Online Data Services unveiled IdeaConnection.com, a website that allows intellectual property owners to post their technologies for sale or licensing for free.

The company said that more than 8,000 technologies are currently available for sale or license in areas such as aeronautics, biotechnology, chemistry, communications, engineering, food science, geophysics, alternative energy, nanotechnology, and computer science.

Access to the site is free, ODS said. There is no charge to post a technology for sale or license or to list a technology that is wanted.

The company also said that licensees or purchasers may contact each other directly with no fee, and negotiate their own terms for the licensing or purchase of the technology. IdeaConnection.com does not collect a fee or percentage of any technology transfer deals.

U of Oregon Announces Venture Development Fund Awards

The University of Oregon announced that it has awarded six grants totaling $191,849 from its University Venture Development Fund, a tax-incentive program created in 2007 by the Oregon Legislature to help realize the commercial potential of research at state universities (see BTW, 10/15/2007).

Three of the recent awards will support life science or biomedical projects, including:

$30,000 to advance work by chemistry professors Andy Berglund and Michael Haley that may lead to a drug for myotonic dystrophy, the most common adult form of muscular dystrophy.
$30,142 to biology professor Shawn Lockery of the UO Institute of Neuroscience to develop a microscopic fluid system that rapidly evaluates new drugs for combating parasitic worm infections such as river blindness in humans and animals.
$31,120 to test a novel magnetic resonance imaging coil created by physicist Jolinda Smith of the UO Lewis Center for Neuroimaging and development engineer Clifford Dax of the UO Technical Sciences Administration.
So far, UO has awarded a dozen grants totaling $449,857 through the UVDF.

TEDCO Gives 10 Company-University Partners Tech-Transfer Funding

The Maryland Technology Development Corporation announced that 10 Maryland technology companies have received $726,710 in total funding.

Each company received approximately $75,000 from TEDCO's Maryland Technology Transfer Fund, a program designed to foster greater collaboration between businesses and Maryland universities and federal laboratories in order to bring technology into the marketplace.

A number of biomedical projects received awards, including:

• Aparna Biosciences, located in Rockville, Md., which is working with the University of Maryland, Baltimore, to develop a biomedical nanoparticle technology for a new class of antifungals that will be used for life-threatening fungal infections in critical care situations.

• CCC Diagnostics, located in Baltimore, which is working with the University of Maryland, Baltimore, to further develop technologies to assist physicians in designing personalized treatment regimens for patients fighting breast, lung, colon, gastric, esophageal, and pancreatic cancers.

• Encore Path, located in Baltimore, which is working with the University of Maryland, Baltimore, to further develop and commercialize clinically proven stroke rehabilitation devices developed at UMB, including a bilateral arm trainer with rhythmic auditory cueing.

Angion Biomedica Inks Option Agreement with MSKCC for Vaccine Tech

Angion Biomedica has signed an exclusive world-wide licensing option with Memorial Sloan-Kettering Cancer Center in New York for a vaccine platform.

The vaccine platform, developed by MSKCC professor Samuel Danishefsky, enables presentation of multiple carbohydrate antigens on a single synthetic scaffold and has been shown to trigger an in vivo immune response to multiple oncology-related targets.

The vaccine scaffold can be customized for various clinical indications. Angion has planned to begin a Phase I clinical trial in early 2009.

UT Southwestern Using WaferGen's SmartChip in Wound Care Studies

The University of Texas Southwestern Medical Center will use WaferGen's real-time PCR system in its gene expression biomarker research, the company said.

Under the collaborative agreement, UT Southwestern will use the company's SmartChip system to identify and validate biomarkers related to wound healing, and it will study the impact of those biomarkers on patient response to treatment.

The research may lead to discovery of specific genes related to wound healing that could be used to develop new tools for determining appropriate treatments, said Fremont, Calif.-based WaferGen.

RNAi Shop Kylin Therapeutics Wins $1.2M from Indiana 21st Century Research and Technology Fund

Kylin Therapeutics, a company based at Purdue Research Park in West Lafayette, Ind., has been awarded a $1.2 million grant from Indiana's 21st Century Research and Technology Fund toward commercializing its disease fighting technology.

The technology, called pRNAi, is a Purdue University platform that uses RNA interference to directly target disease-causing genes. Kylin is in the pre-clinical stage of further developing the technology to target drug delivery for treatment of diseases ranging from AIDS to cancer.

Formed through a joint effort between IN-vivo Ventures and North Carolina-based Golden Pine Ventures, Kylin Therapeutics acquired an exclusive license to pRNA from Purdue in 2007.

Kylin Therapeutics is one of 59 businesses awarded a 21st Century Fund grant since January 2006.

EKU Establishes Center to Explore Sustainable Biofuel

A partnership between Eastern Kentucky University and California-based General Atomics could provide the basis for a new and sustainable fuel production industry in Kentucky that could ultimately have a global impact.

With the establishment of the Eastern Kentucky University Center for Renewable and Alternative Fuel Technologies (CRAFT), researchers will examine the potential for a cellulose-derived biodiesel industry in Kentucky.

By using algae techniques to process cellulosic materials that are available in Kentucky, the project offers both a technological underpinning for sustainable fuel production and a technology that could benefit agriculture in Kentucky.

General Atomics, headquartered in San Diego, Calif., was founded in 1955 and specializes in diversified research, development and manufacturing in defense, energy and other advanced technologies.

Kentucky Receives $12.5 Million to Fund High-Technology Research

Kentucky has been awarded $12.5 million from the National Science Foundation (NSF) that will be used to fund university research in three key technological areas: biotechnology, nanotechnology and cyber-technologies. The major recipients are the University of Kentucky and University of Louisville. Other institutions involved include Kentucky State University, Northern Kentucky University, Eastern Kentucky University, Centre College, Berea College and Morehead State University.

The five-year award, made through Kentucky’s Experimental Program to Stimulate Competitive Research (EPSCoR), is expected to be matched with an additional $5 million from the commonwealth over the life of the grant.

Kentucky joined the EPSCoR Program, an initiative of the Kentucky Science and Technology Corporation (KSTC), in 1986 and today is one of its most successful members. Kentucky’s program supports 178 active research projects with budgets totaling over $139 million.

In terms of federal academic research and development dollars secured, Kentucky ranks in the top five out of the 25 states eligible to compete for funding and is recognized for more than doubling its share of federal research funds since the program’s inception.

The Pittsburgh Life Sciences Greenhouse Relocates Therapeutics Company to Pittsburgh while Cognition Therapeutics, Inc. Begins Operations with a $200,000 Investment from the PLSG

The Pittsburgh Life Sciences Greenhouse (PLSG), the organization providing capital investments and customized company formation and business growth services to the region’s life sciences enterprises, announced that the PLSG has helped Cognition Therapeutics, Inc. (Cognition) make the decision to relocate to southwestern Pennsylvania and has invested $200,000 in the Company. In addition, the PLSG has assisted Cognition in establishing regional operations and has provided connections to additional capital and equipment sources. The Cognition team is occupying office space in the PLSG Incubator and laboratory space on the South Side.

Cognition is an early-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics targeting the toxic proteins that cause the cognitive decline associated with Alzheimer's disease and other degenerative diseases of the human brain.

Akrimax Pharmaceuticals, which purchased a Wyeth facility in New York, US, Has Signed Its First Third-Party Agreement.

The contract manufacturer purchased Wyeth’s Rouses Point facility in January 2008 in a deal that saved the plant from closure. The drugmaker leases space back to Wyeth with the latter continuing to make product there during an interim period while Akrimax starts its own production.

Wyeth plans to have completely exited the plant by the end of this year, with Akrimax becoming the employer of record on January 1, 2010, although the transition period could last until 2011.

At one point Rouses Point had been a major manufacturing facility for Wyeth’s hormone replacement therapy range Premarin (conjugated estrogens). However, that product has experienced significant sales declines significant reduction in overall sales volume on concerns that the products can increase the risk of breast cancer and stroke.

Akrimax declined to name the customer, limiting itself to saying that it is a “global healthcare company.” The company’s president, Alan Rubino, said the deal had come in “ahead of our planned schedule” and “validates Akrimax's decision to acquire the Rouses Point facility.”

The company said it was selected from several potential partners in a competitive tender process.

The production contract is due to get underway shortly, according to the drugmaker, whose primary business is the in-licensing of established pharmaceuticals that can be used to treat metabolic syndrome, a combination of high blood pressure, high cholesterol, diabetes and abdominal obesity.

As part of the agreement with Wyeth, Akrimax also acquired patent rights to two pharmaceutical products, Inderal LA (long-acting propranolol hydrochloride capsules) for cardiovascular disease and the contraceptive product Lo/Ovral (norgestrel and ethinyl estradiol tablets), as well as arrange of over-the-counter medicines.

Akrimax bought the 950,000 sq. ft. facility, with the exception of a unit carrying out chemical development - for a little over $7.86m.

Wyeth said in November that it was planning to lay off 118 of the 725 workers at the plant later this month. For its part, Akrimax has said it plans to recruit up to 200 new employees over the next couple of years.

Drug Raw Materials Maker Akron Biotechnology Selected Austin Chemical Company to Expand Its Client-Base in Global Biotech, Pharmaceutical, and Diagnostic Industries

Austin Chemical is a specialist provider of sales, marketing, and distribution services including import export, storage, shipping and customer invoicing. At present the firm distributes more than 8,000 products to over 1,300 end users worldwide on behalf of 115 client companies.

Akron Biotech, which is focused on the production of drug raw materials for next generation pharmaceutical and biotechnology applications, said that through the partnership Austin would supply its full catalogue of products to the drug industry.

These include Akron’s line of bulk animal and human products, chemical reagents, recombinant proteins, monoclonal antibodies for development and serum-free media.

Commenting on the accord, financial terms of which have not been released, Akron CEO Claudia Zylberberg said that: “Akron’s high quality products and Austin’s excellent reputation and established presence creates a mutually beneficial relationship.”

“Austin has been in the business of bridging business and science for over 30 years,” added Austin CEO Samuel Ponticelli.

He went on to say that because Austin “mainly focuses on representing chemical manufacturers, we see changes in the industry, and realize that an expanded biotech products portfolio as offered by a high quality source, like Akron, will answer the demands of our customers.”

The new deal is a further example of Akron’s recent efforts to boost its client base. In December the firm launched the e-commerce section of its website.

At the time sales and marketing director Debra Kezar explained that: "In this economy, it is important to invest in marketing tools that will give you better ROI and will maximize our resources."

Packaging Deal between McKesson and Burgopak is Evidence of Determination to Improve Patient Compliance

Aside from the significant health risk to patients, non-compliance costs around $177bn a year, based on both wasted drug production and indirect costs such as lost workplace productivity.

As a result drug makers and regulators worldwide are keen to improve patient compliance through any means available, including making alterations to the way pharmaceuticals are packaged.

The Burgopak packaging system that McKesson gains access to under last month's deal uses a central sliding band that contains a 'Pull' component, which can be either a piece of cardboard or a product blister, attached to a drug information leaflet.

Symonds explained that: “The benefit to patient compliance is the guaranty that the booklet is always conveniently attached to the 'Pull' component and so always available for reference.

“The [drug] product is always attached to the package through the sliding band, ensuring the component is always protected by the package's outer carton.”

Symonds added that Burgopak manufacturing machine, which is produced on the firm’s behalf by Switzerland’s Sigpack Systems, would be installed at McKesson's facility in Memphis, Tennesee in early 2010.

He went on to say that while: “terms of the agreement with McKesson are confidential. Burgopak will be happy to discuss the use of Burgopakss in the US with pharmaceutical companies and others.”

Symonds explained that the technology was being used by Bayer for its Rennie ‘Ice’ product and the Healthcare Branding Company for its PocketPak paracetamol and ibuprofen products and added that further major drug industry clients would be announced this year.

In a press statement Kirk Kaminsky, VP of McKesson’s pharmaceutical packaging business said: “McKesson RxPak is proud to be the first U.S. packaging company to provide Burgopak’s award-winning compliance packaging to pharmaceutical manufacturers and healthcare consumers in the US,” said Kirk Kaminsky.

“McKesson is committed to delivering solutions that help improve patient health outcomes, and our new licensing agreement with Burgopak can enable us to do this by addressing many of the reasons why consumers are noncompliant when it comes to taking their medication,” he added.

Microfluidics Formalised Partnership with Horiba Instruments

The companies will now collaborate on R&D, share lab space and jointly help clients through a single contract.

Previously the two companies have shared marketing efforts, such as seminars and joint customer presentations, but this has been expanded upon under the new agreement.

The two companies believe their complementary technology and expertise, covering advanced fluid processing and analytical instrumentation, will allow them to provide a better service to clients than they could operating independently.

Michael Pohl, Horiba’s vice president of scientific instruments, said: “The relationship between Microfluidics and Horiba has always been mutually advantageous, but our customers will be the true beneficiaries of this new partnership.

“They will receive the combined expertise of both companies through a single contact and we are excited about the synergy these efforts will generate.”

The belief that the partnership will be synergistic is underpinned by the knowledge that many clients already use its Microfluidizer processor in conjunction with Horiba’s particle size analyser.

Consequently joining forces should enable the companies to better serve these customers and improve research. This will cover research into new technologies and improvements to existing products with the companies sharing lab space and tangible resources.

In addition the companies will share exhibit booths at trade shows and pool resources for advertising and lead generation.

FDA Forces Actavis to Shut Down Plants

Generic drug maker Actavis has agreed to shut down several plants in New Jersey until they meet U.S. quality standards for the testing and manufacturing of pharmaceuticals.

The Food and Drug Administration said it has filed a consent decree which will bar Actavis Totowa from making or distributing drugs from its plants in Totowa and Little Falls, N.J.

Under the agreement, executives Sigurdur Olafsson and Douglas Boothe will be able to resume production only after FDA confirms the plants meet U.S. regulatory standards.

The agreement also allows FDA to shut down the plants again if violations continue, and to fine the company $15,000 per day thereafter, up to $7 million per year.

FDA said it filed the action against Actavis Dec. 23 in U.S. District Court of New Jersey, and is awaiting a permanent injunction against the company.

Actavis Inc. and Actavis Totowa LLC are units of Iceland-based Actavis Group.

In April, Actavis recalled its generic heart drug Digitek because some tablets may have been twice as thick as they were supposed to be, which would have doubled the dose and created a greater risk of side effects.

In inspections last spring, the FDA found the company kept incomplete lab records of its testing data, and failed to verify that its testing methods matched up with actual conditions under which the products would be used. The company also made drugs at the Little Falls facility that had not been approved by the FDA.

"The FDA will not allow manufacturers to put the public's health at risk," FDA drug center Chief Janet Woodcock said in a statement. "These unapproved new drugs have not undergone FDA review for safety and efficacy and may pose potential health risks."

The federal Department of Justice filed its initial lawsuit against the company in November.

Halo Pharmaceuticals Acquires Abbott Laboratories’ 200,000 sq. ft. Formulation, Manufacturing and Warehousing Facility in Whippany, NJ

Halo Pharmaceuticals hopes that its acquisition of Abbott Laboratories’ 200,000 sq ft formulation, manufacturing and warehousing facility in Whippany, New Jersey will help it blossom into a CMO and development organisation.

Through the deal Halo gains aseptic filling capacity for solid, liquid and topical dosage forms, as well as several packaging lines and considerable laboratory space that it plans to use for its preclinical and clinical development offering.

The site also holds US Drug Enforcement Administration (DEA) clearance for the manufacture of controlled drug substances and active pharmaceutical ingredients (APIs), which should serve the new firm well given the growing market for high-potency APIs.

The sale, financial terms of which are not being released, was first mooted in October last year as part of Abbott’s wide ranging consolidation strategy that has seen it focus on core products like Humira (adalimumab).

Halo president Douglas Kollmorgen said that the firm will retain 80 of the 134 staff previously employed at the site, explaining that the skilled and experienced workforce was a key motivation for making the acquisition in the first place.

This aspect of the purchase in particular is welcome news for New Jersey which saw companies like Par, Johnson & Johnson and Roche cut staffing levels at facilities in the region in 2008.

This Whippany facility’s track record was also emphasised by Halo’s vice president of quality, John Garvey, who commended Abbott for fostering a culture of regulatory compliance and diligence.

“These important foundational elements will enable the creation of a systems approach to quality with a focus on science-based, product-driven control frameworks that meet or exceed current [US Food and Drug Administration] FDA regulatory requirements,” added Garvey.

Pharmaceutical Product Development Inc (PPD) Purchased a 130,000 sq. ft. Laboratory from Merck

Contract research organization Pharmaceutical Product Development Inc (PPD) has moved further into providing central laboratory services with the purchase of a 130,000 sq. ft. laboratory from Merck & Co.

The deal sees PPD take over the vaccine testing and assay development lab – including more than 80 Merck staff – and provide services to Merck in the areas of assay development and immunogenicity testing. Terms of the agreement have not been disclosed.

The agreement is reminiscent of Eli Lilly’s groundbreaking 10-year, $1.6bn agreement with Covance last year, which saw the drug major sell off its Greenfield Laboratories facility to Covance, including 260 staff, with the CRO providing toxicology, pharmacology and other R&D work to Lilly as a paid-for service.

This is a path that is already well-trodden in pharmaceutical manufacturing but less common in R&D. Faced with surplus capacity at facilities drugmakers are increasingly electing to sell off plants, to management buyout teams or contract service providers and often with legacy contracts thrown in, in order to reduce overheads.

Under the terms of the Merck/PPD deal, the CRO will provide central laboratory and sample storage services to Merck for its clinical development activities over a period of five years.

In a statement, PPD said the acquisition “significantly expands [our] overall global central laboratory business, adding world-class vaccine and biologic testing, assay development and sample storage capabilities to its current suite of laboratory services.”

The company also said it plans to invest in the lab by developing new technologies and assays to expand its immunochemistry and oncology vaccine testing services as well as biologics lab services for other biopharmaceutical clients.

PPD is one of the largest CROs in the sector, with a $5.1bn market cap that leaves it second only to Covance with a $6.1bn value. The company has seen some softening in its CRO business of late – marked by a slowdown in new business authorizations and a higher than usual cancellation rate – but has continued to invest for future growth.

Oakland University Plans Healthcare-Research Park within Rochester Hills, Mich., Campus

Oakland University in Rochester Hills, Mich., will break ground next year on a 157,300-square-foot Human Health Building that will house the nursing and health sciences schools and a public health clinic.

The facility is the first in a set of sites intended to transform the northwestern corner of its campus into a research and healthcare hub. Next up will be a new William Beaumont School of Medicine building, followed by a facility that would house a specialized patient treatment center, drug trials, and more research.

The three structures that will comprise the still-unnamed research park will likely not be complete until 2014. Oakland County Executive L. Brooks Patterson said the campus plan "fits in very nicely with our plans to brand the region as a center of excellence in health care," in part through its “Oakland Medical” healthcare marketing effort.

"The research component is going to be very powerful for us," Oakland University President Gary Russi said, "Not only basic research in health care, but applied research in the treatment of diseases. This is a huge mega-structure that we are talking about that will have (a great) impact in this area."

The effort comes a year after the university revealed plans for the state's first medical school in four decades. While a full economic impact study has yet to be conducted, OU has estimated the medical school alone will generate $1 billion in economic activity, and 11,000 new jobs, with the research park to add additional jobs.

Oakland County is Michigan’s leading county for the number of health care establishments with 4,300, and number two behind Wayne County for the number of health care and life sciences jobs, with 93,000, according an Anderson Economic Group study commissioned by OU, the county, Beaumont Hospitals, and McLaren Health Care Corp. The study said Oakland County could add another 45,000 healthcare and life-sci jobs over the next decade.

Thermo Fisher Scientific Spent Nearly $14M for Franklin, MA, Industrial Space

Thermo Fisher Scientific has purchased its leased facility at 27 Forge Park in Franklin, Mass. — a one-story, 110,756-square-foot industrial building completed in 1996 — from seller Embarcadero Capital Partners for $13.95 million, real estate market tracker CoStar Group reported.

Situated on 16.93 acres, the industrial property features 600 parking spaces, two loading docks and a clear height of approximately 21 feet.

Amarillo Biosciences Will Accept Incentives toward Move from Texas to Kansas

Amarillo Biosciences CEO Joe Cummins said his company will accept a financial incentive package to move from its namesake Texas city to a city in Kansas willing to provide millions of dollars, but which he declined to identify pending a formal announcement.

"It's not that I don't like Amarillo," he said. "It's just difficult to find money here,” Cummins told the newspaper. "Since raising $1 million in January 2008 from a hedge fund in New York City, the equity markets have dried up. Therefore, we have been searching for funding everywhere."

Five other cities are waiting to woo the company if the deal in Kansas falls through. He said his company has also contacted the Amarillo Economic Development Corp. about obtaining subsidies tied to job retention and growth.

Amarillo Biosciences has developed a solid, dissolvable form of the antiviral protein interferon, and has nearly completed a Phase II clinical trial for treating oral warts in HIV patients. Amarillo Biosciences also is testing the therapy on hepatitis C patients in Taiwan and flu patients in Western Australia.

MedImmune Months Away from Breaking Ground on Gaithersburg, Md., HQ Expansion

MedImmune will start construction within the next six months on a seven-story, 250,000-square-foot research facility set to nearly double the space the company occupies at its Gaithersburg, Md., headquarters.

The new facility would be completed by late 2011 and is the last building to rise according to MedImmune's master plan, which envisions a total 750,000 square feet of space. To comply with a green-building law enacted last September, the building must meet the “silver” standard of the US Green Building Council's Leadership in Energy and Environmental Design program.

MedImmune’s HQ campus now houses five attached buildings totaling 463,000 square feet.

Once the new building is finished, MedImmune envisions having 4,500 employees on campus — up from the 2,500 reported in 2007, when the company was acquired by UK-owned AstraZeneca for $15.6 billion. "I think that [in 2008], we already met our expectations of 800 hired, and we expect to hire another 800 [in 2009]," said Perla Copernik, company spokesperson.

In addition, MedImmune is also nearly quadrupling the size of a 91,000 square-foot manufacturing facility it owns in Frederick, Md. The company is adding 355,000 square feet to the factory, where MedImmune manufactures Synagis, a medication designed to help prevent serious lower-respiratory tract disease caused by respiratory syncytial virus in children.

University Breaking Ground This Month on Smithfield, PA Tech Park

East Stroudsburg (Pa.) University's Center for Research and Economic Development plans to break ground this month on a $11.25 million, 51,000-square-foot Research and Technology Park at Route 447 and East Brown Street.

The building will be complete in September and occupied soon after, according to the university.

The new facility could create 90 new jobs next year, with an additional 133 fostered indirectly, according to an economic impact study by the Northeast Pennsylvania Alliance, a regional economic development organization. The study also concluded that total economic impact could be as much as $26 million next year and rise as high as $85 million in 2011.

The building will feature class A office space for anchor tenants such as Right Reason Technologies, a Web-based training company, and the Energy & Research Technology Hub, which is looking for alternative energy sources for the manufacture of boilers.

The research and technology center will offer 11,000 square feet — in the form of office space and wet labs — for 12 to 15 startups. The center has received enough letters of intent to fill all the spaces, but is still marketing its staff to tenant prospects.

Incubator businesses range from software and Web design firms to biotech and light manufacturing concerns. In addition, the building will house the Northeast Wildlife DNA Laboratory, which provides services to determine and differentiate genetic variation within wildlife for biological and forensic applications; and the Cyber Crime and Forensics Institute, a project of ESU, Drexel and Rider universities designed to train investigators and carry out research in cyber forensics.

The center now houses 12 startup companies in business accelerators scattered from East Stroudsburg to Stroudsburg.

The three-story, glass and brick research and technology park was designed by Hemmler+Camayd architects, and was built with public and private funds. That includes more than $3.75 million from the state of Pennsylvania — $2.5 million from a Redevelopment Assistance Capital Project grant, $1.2 million from the state's Economic Development Administration and another $75,000 from the Appalachian Regional Commission, which is a partnership of the federal government and 13 Appalachian states.

The remaining $7.5 million will be raised through loans from three different banks, with monthly repayments to be covered mostly through rental income.

Firm Completes Design for Flint, Mi, Incubator, to Anchor Kettering Univ. Tech Park

The architectural firm SHW Group’s Detroit studio has completed its design for a new Science and Technology Incubator facility at Kettering University in Flint, Mich. The 9,000-square-foot standalone structure will overlook the Flint River and anchor the university's planned Technology Park.

Amenities in the facility, to rise on Bluff Street, near the Flint River, will include a business center, furnished offices, a conference room with high-tech audio/video systems, a café vending and seating area, and a reception area.

The private space will house six wet and dry research laboratories. Each lab will be approximately 700 square feet, with completion slated for late 2009.

The incubator will be built to meet standards of the Leadership in Energy and Environmental Design program of the US Green Building Council, SMW said.

Bucks Community College, Tech Company Take 4,700 Sq. Ft. at Bristol, PA R&D Complex

Two tenants have agreed to lease a total 4,700 square feet at a recently renovated building within the nearly $30 million Bridge Business Center, a research-and-development complex being built in Pennsylvania’s Bristol Township by Keystone Redevelopment Group of Doylestown, Pa.

Bucks County Community College will house a chemistry lab, classroom and two offices within its 3,500 square feet of space, where it plans to offer three chemistry classes beginning Jan. 21. The remainder of the space will be occupied by an unidentified “technology company that does work for the defense industry, which plans to move in February”. The two tenants will move into a 50,000-square-foot building, one of several totaling 310,000 square feet of space renovated from industrial use by previous owner Rohm and Haas, until it was acquired by Dow Chemical.

In addition, Keystone has rights to build another 60,000 square feet of new industrial and industrial/office “flex” spaces, to be sold condominium style. Keystone has acknowledged that its ability to fill the renovated buildings, let alone build the new space, on 35 acres along the Delaware River has been hampered by the current economic upheaval: “We do recognize the slowdown and the challenges of next year," said Robert Loughery, managing member of Keystone.

Last year Pennsylvania awarded Keystone $6 million from its Building PA program toward the project. Pennsylvania expects the project to help advance the state’s goal of expanding its life-sci sector beyond the 1,751 businesses and 72,000 jobs recorded in 2007, the latest-available figure.

Clarksville Opens $200-Million Medical Center

There was a June grand opening of Clarksville's new, $200 million Gateway Medical Center. With the new hospital, community leaders hope Clarksville, TN, is now asserting itself globally with another vital physical component worthy of its designation as Tennessee's fifth-largest, and fastest-growing city.

Competitive health care delivery in a techno-savvy and bigger facility to meet the demands of growth — these are the standards by which the city's new Gateway hospital has been built.

After a year of construction along the 60-acre site, preceded by several years of gathering both in-house and community consensus on the need for the new hospital, it is now receiving patients.

The new hospital is also the catalyst for other dramatic retail and residential growth that's occurring around St. Bethlehem and all along Interstate 24.

The new hospital boasts 490,000 square feet with plenty of room to grow. It has 270 licensed beds, 128 private patient rooms, 65 semi-private rooms and a 12-bed, neo-natal intensive care unit.

The new 40-bed emergency room is double the size of the old Madison Street ER.

Kansas City and St. Joseph Missouri Area Called Animal Health Corridor with Expansions Despite Economic Hard Times

Kansas State University in Manhattan has been selected for a new $563 million federal laboratory focused on fending off biological threats to livestock and agriculture. When completed, the lab will employ 500, including at least 300 scientists. The presence of the Animal Health Corridor and its 125 companies focused on animal health is regarded as a key advantage. And St. Joseph is a big part of the corridor. There is hope that vaccines developed in the federal lab someday could be manufactured here.

The University of Missouri is proposing a new 500-acre public/private research park in Blue Springs, on the eastern edge of Kansas City. A national developer will be sought for the project, which will require $50 million to $70 million for roads and other infrastructure and include a Mizzou Innovation Center devoted to bioscience research, continuing education and student recruitment.

Johnson County, Kan., approved a one-eighth-cent sales tax last month to pump $15 million a year into education and research. A key beneficiary is the National Food and Animal Health Institute to be built on Kansas State’s new Olathe campus. The institute is expected to offer from 10 to 15 master’s degrees and 20 to 30 certification programs to perhaps 1,000 students. Construction costs are estimated at $28 million.

In St. Joseph last month, the City Council pledged its support for industrial revenue bonds to benefit Boehringer Ingleheim Vetmedica Inc. The bonds will finance expansion of the manufacturer of animal health products and pharmaceuticals. The expansion is projected to create 124 full-time jobs between 2009 and 2013 with a local investment of nearly $130 million.

The Missouri Life Science Trust Fund recently awarded $285,000 to the Bond Science and Technology Incubator at Missouri Western State University. The money will be used to build a cleanroom, for testing manufacturing processes used by start-up life sciences businesses.

These developments are in addition to this fall’s announcement that Imulan BioTherapeutics, which is developing feline medicines, will become the first tenant of the new incubator at Western.

AdvantaPure Expands Its Silicone Molding Operations to Meet Increased Product Demand

High purity tubing and hose manufacturer AdvantaPure, Southampton, PA, recently tripled the size of its cleanroom facility to allow for the increased production of molded silicone components. Manifolds and other process components for the pharmaceutical and clean application industries are produced in a newly created area. The original cleanroom is now used primarily for the manufacture of silicone stoppers and sealing systems for containers of glass, metal, or plastic.

“The number of orders coming in for molded products was quickly rising,” notes Michael Needling, AdvantaPure’s Director of Manufacturing Operations. “Seeing this, we planned and built the new space before we reached capacity in the existing room. We now have several team members producing manifolds and stoppers full time. And the new area has room for additional expansion.”

The new space houses several liquid injection molding (LIM) stations used in the production of silicone manifolds, along with work tables, storage areas, and an R&D section. A separate

cleanroom, which was also part of the facility expansion, is used for manufacturing and packaging hose assemblies and for pressure testing. Access is restricted to essential team members in both HEPA-filtered rooms to maintain product purity. The company’s plant engineer and maintenance personnel handled construction.

AdvantaPure uses its expanded space to manufacture custom single-use silicone manifolds consisting of tubing; fittings in T, Y, cross, and reducer styles; and other specified components. Sealing systems and stoppers, with or without ports for tubing inserts or vents, are produced for flexible container systems, carboys, laboratory apparatus and bottles, and sampling and storage receptacles.

At $28 a Square Foot, Mass. Life Sciences Center Leases New HQ Space in Boston Suburb

The Massachusetts Life Sciences Center — the quasi-public agency that oversees the state’s $1 billion, 10-year Life Sciences Act — announced it will lease 5,855 square feet at an office park in the Boston suburb of Waltham, Mass.

The life-sci center will pay $28 per square foot for its space starting next year, said spokesman Angus McQuilken. The center will be located at 1000 Winter Street, a four-story building within the Bay Colony Corporate Center, a 968,831-square-foot office campus located on 58 acres overlooking the Cambridge Reservoir and Route 128.

March 1 is the date targeted by the center for moving in.

“This is a location that allows accessibility for life sciences stakeholders across the state, because we are a statewide center and this is a statewide initiative, and not meant to serve just one region of the state,” McQuilken said in an interview.

The center’s President and CEO Susan Windham-Bannister, said in a press release that the center made its leasing decision “with an eye towards accessibility and fiscal responsibility, as this space is less expensive than in other areas we considered.”

In addition to the new headquarters, the center said in an announcement, it will maintain “a small workspace” in Boston. Until now, the center had shared space in with the state’s Executive Office of Housing and Economic Development in a state government building downtown Boston.

Bay Colony is owned by Broadway Partners, a private real estate and investment firm headquartered in New York City. Sue Donovan, senior vice president of the real estate firm DTZ FHO Partners, represented Broadway Partners in lease talks; Peter McDonald of McDonald Real Estate Ventures represented the center.

University of Michigan Eyes 2,000 New Jobs in Ex-Pfizer Campus in Ann Arbor

The University of Michigan’s Board of Regents last week approved plans by the university to purchase the 2 million-square-foot former Pfizer lab-office campus in Ann Arbor for $108 million,

The 174-acre site, adjacent to U-M’s North Campus, includes 30 laboratory and administrative buildings, as well as amenities and open land. UM said it projects the acquisition will create 2,000 researcher and research support jobs over the next decade, as well as enhance its ability to foster academic-business research collaborations.

“The University of Michigan has taken a critical step in advancing our work in health, biomedical sciences and other disciplines,” U-M President Mary Sue Coleman and Robert Kelch, executive vice president for medical affairs, said in an e-mail message to university staffers and students soon after the regents’ Dec. 18 action. “We are increasing our capacity to contribute as one of the great research universities, while creating jobs that ensure our region’s intellectual and economic vitality.”

U-M said it expected to close on its purchase in June 2009, using funds drawn mostly from U-M Health System reserves, as well as some investment income.

Ann Arbor Mayor John Hieftie issued a statement saying the deal had “troubling aspects to it” since the site would come off the city’s tax rolls; the city received 28 percent of the roughly $2.5 million in taxes generated by the property last year. He added: “If the U-M is able to greatly expand life sciences research in Ann Arbor it will have far reaching, long-term economic benefits for the whole region.”

Pfizer has all but shuttered the campus, which employed 2,100 people before the pharma giant’s announcement of January 2007 that it would close the campus. The shutdown has come at a time when Ann Arbor has seen a flurry of activity from early-stage therapeutics and medical device companies.

Charles River Labs Plans $20M Charleston, SC-Area Warehouse/Research Site

Charles River Laboratories International is planning a new $20 million warehouse and research site in the Charleston, SC, area that will generate 60 new jobs.

Foster Jordan, a senior vice president with Charles River Labs, cited South Carolina’s workforce, innovation and commitment to the life sciences as factors in the company’s decision to expand operations there. The company did not disclose exactly where or when the project would be built.

Charles River Labs has been in an expansion mode in recent months, opening a 60,000-square-foot preclinical services facility in Shanghai and a 52,000-square-foot research laboratory in Frederick, Md., with the goals of better serving a key customer, the National Cancer Institute, and other customers in the Washington, DC, region.

UCSF Wins $25 Million from Broad Foundation toward $123 Million Stem Cell Headquarters

The Eli and Edythe Broad Foundation has donated $25 million toward the stem cell program of the University of California, San Francisco. UCSF said the funds will be put toward the construction of a $123 million headquarters for the program on the school’s Parnassus Campus.

The new facility will include 25 labs involved in various areas of human and animal embryonic and adult stem cell and related early-cell studies. Designed by architect Raphael Viñoly, the building is a series of four split-level floors with terraced grass roofs and solar orientation. Open labs flow into each other, with office and lounge areas located on the circulation route between the labs. The building will be connected by an enclosed walking bridge to inpatient and outpatient clinics at UCSF Medical Center, a design feature intended to support the goal of translating basic research findings to clinical trials.

Construction of the building began in September — the projected cost has risen from the $119 million figure cited last September — and is scheduled for completion in mid-2010.

UCSF will rename its Institute for Regeneration Medicine the Eli and Edythe Broad Center of Regeneration Medicine and Stem Cell Research at UCSF.

The Broad Foundation is the largest non-governmental donor to stem cell research in California, having given $75 million to support or create stem cell centers at UCSF, as well as at UC-Los Angeles and University of Southern California.

Researchers based at UCSF have received 27 research grants and two facilities grants from the California Institute for Regenerative Medicine, the state’s stem-cell research and facilities funding agency, for a total of about $82.4 million, not counting the UCSF-affiliated J. David Gladstone Institutes, which have received 10 research grants and one facilities grant, for a total of nearly $8.8 million.

In addition to the Broad donation, the new facility has been funded through a $34.9 million grant from CIRM awarded in May 2008, and a $16 million donation from Ray and Dagmar Dolby, who launched UCSF’s fund raising campaign for the building in 2005.

Colorado State Set to Start Construction on $53M Biotech Incubator/Research Center
Colorado State University said it plans to start construction Dec. 17 on a new $53 million, 72,000-square-foot biotechnology business incubator and Research Innovation Center.

The building will be located within the Judson Harper Research Complex on the Foothills Research Campus, and serve as an addition to CSU’s 38,000-square-foot Rocky Mountain Regional Biocontainment Laboratory, completed in October 2007 on the Foothills Campus. Anticipated completion date for the incubator/research center project is spring 2010.

Signature Genomic Laboratories Leases Expansion Space in Spokane, WA

Signature Genomic Laboratories has leased 4,600 square feet of office space in downtown Spokane, Wash., an expansion the microarray-based cytogenetic diagnostics provider said was needed due to growth since June, when Signature relocated its headquarters and laboratory within the city to 2820 N. Astor St., an 18,500-square-foot former Sears Roebuck and Company distribution center.

Signature’s new space, in Schade Towers, will house Signature's finance, sales, marketing, business development and information technology departments.

Vivus Renews Lease for Columbia, Md., Headquarters at an 11 Percent Discount

Vivus, a pharmaceutical company in Mountain View, Calif., has extended the lease it signed two years ago on its corporate headquarters at 1172 Castro Street, and will see its rent reduced from $1.85 per square foot to $1.64 psf — which in turn will lowering the current monthly payment from $26,338 to $23,349 starting Aug. 1 and expiring July 31, 2011, according to a company filing with the US Securities and Exchange Commission, the Mercury News of San Jose, Calif., reported.

Hemagen Diagnostics Cuts Space in Lease Renewal for its Columbia, Md., Headquarters

Hemagen Diagnostics said in a recent filing with the US Securities and Exchange Commission that it will reduce the space it uses in its Columbia, Md., facility from 27,400 square feet to 20,100 square feet by June 30, 2009, under an extended lease that runs through June 30, 2012.

The facility, at 9033 Red Branch Road, is where Hemagen maintains its principal administrative office, laboratory and production operations. Under the extended lease, Hemagen will pay about $206,000 per year in rent during its upcoming fiscal year. The company also said it has received a commitment from the landlord to subsidize $154,400 in the form of a tenant improvement allowance.

The company recently restructured its operations to focus primarily on veterinary clinical diagnostics and its Virgo human clinical diagnostic line of autoimmune and Infectious disease products.

CMC Icos Halts Expansion in Seattle, WA

The global economic downturn has put the breaks on US CRO CMC Icos’ $35m expansion plans as the firm opts to put the scheme on hold in an effort to limit its spending over the next few years.

The contract research organisation (CRO) unveiled a scheme to expand its production facility in Bothwell near Seattle in September. CMC had planned a five-fold capacity increase by 2010, doubling its 141-strong manufacturing workforce.

CMC president Gustavo Mahler said: “Postponing the project enables us to forego significant spending and helps ensure that we retain sufficient resources to better weather the economic slowdown.”

Mahler explained that: “The current challenges of the global economy, we must carefully manage our resources” and added that the firm has not issued a new completion date for the project and would not be doing so in the near future.

CMC’s position must be particularly galling for the firm given the expected growth of the monoclonal antibody market in the next few years, particularly as it was named among the key industry players in a recent Global Industry Analyst (GIA) study.

In 1994 the only monoclonal antibody drug to be approved by the US Food and Drug Administration (FDA) was Eli Lilly’s ReoPro (abciximab) for the treatment of cardiovascular disease. Since then the agency has cleared 20 additional therapies, helping expand the market to some $21.9bn last year.

The increasing demand for novel therapies pharmerging markets like India and China is expected to further accelerate the growth of the sector, particularly given the growing prevalence of cancer in the region.

SHW Group Designs Plans for Science Facilities at Kettering University in Flint MI

The Berkley, Michigan office of SHW Group has revealed its design for a new science and technology incubator facility at Kettering University in Flint. The 9,000-square-foot (840-square-meter) stand-alone structure will overlook the Flint River and anchor the university's planned Technology Park.

Amenities in the public space will include a business center, furnished executive and administrative offices, a conference room, and cafe and reception areas. The private space will house six wet and dry research laboratories. Each lab will be approximately 700 square feet (65 square meters) and designed for easy division and addition. Completion is slated for late 2009.

McCarthy Builds Medical Center at University of Texas

McCarthy Building Companies, Inc., a Texas builder since 1980, was recently recognized for its outstanding work on The University of Texas Southwestern (USTW) Medical Center’s Laboratory Research and Support Building. McCarthy received awards from both the Associated Builders and Contractors of North Texas (ABC) and Texas Construction for its superior construction and contribution to the educational industry.

“We are genuinely honored to be recognized by both organizations for our work on the UTSW Laboratory Research and Support Building project,” said McCarthy’s Texas Division President Mike McWay. “We strive to attain excellence in all of our projects, and our work on UTSW spotlights McCarthy’s strong background in building medical research facilities.”

The UTSW Laboratory Research and Support Building is a $27.8-million, four-story, 78,000-square -foot facility providing research and laboratory space to further medical education and research for the 4,200 medical, graduate and allied health students who participate in UTSW graduate programs.

The ABC of North Texas annually recognizes and promotes the outstanding projects built by ABC members on both a local and national level with its Excellence in Construction Awards. McCarthy was awarded the Excellence in Construction Award of Merit in Higher Education in the category for projects valued between $25 million to $100 million. This is the fifth time that McCarthy has received an Excellence in Construction award from ABC of North Texas. Texas Construction selected the UTSW project as a “Best of 2008 Award” winner in the higher education category. The “Best of 2008 Awards” is an annual event that celebrates and honors the building teams that create the best projects in Texas. Winners are selected by an independent jury of industry experts. The “Best of 2008 Award” winners will be featured in the December 2008 issue of Texas Construction.

McCarthy adds these awards to a growing list of awards the company has received from the construction industry.

The Wistar Institute and the University of the Sciences, in Philadelphia, Unveiled a New Molecular Screening Facility at the Institute

The Wistar Institute and the University of the Sciences, both located in Philadelphia, unveiled a new Molecular Screening Facility at the institute, which is part of a larger medical research partnership between them that will seek new compounds for potential therapies.

The $1.1 million screening facility and the Center for Chemical Biology and Translational Medicine combines Wistar’s biomedical research capabilities with the University of Sciences’ chemical and pharmacological expertise.

Researchers will use the screening services at the Molecular Screening Facility to identify and characterize new molecules and compounds that have potential as new therapeutics for cancer and other diseases. Wistar pointed to a recent discovery of a protein involved in cancer growth, and it hopes to continue conducting screening to find molecules that bind to that protein and inhibit its ability to grow cancer.

“Our ability to assess the hits generated by the facility brings the process one step closer to identifying viable drug candidates that, at the end of the day, have the potential for improving healthcare for all people,” University of the Sciences President Philip Gerbino said in a statement.

St. Olaf College Science Hall Goes Green

The Minnesota school's Regents Hall of Natural and Mathematical Science is on track to be the first university building of its size to earn LEED Platinum certification.

This fall, St. Olaf College, Northfield, Minn.,, opened a 200,000-sq-ft, $63 million science facility. If certification for Regents Hall of Natural and Mathematical Sciences goes as anticipated, it will be the first college or university building of its size and use to earn LEED Platinum certification.

According to school officials, Regents Hall, compared to a similar structure that only meets code, will save enough energy each year to power more than 250 homes annually. It is the first U.S. science facility designed to incorporate a green chemistry curriculum using water-based reactions to decrease lab waste and the need for conditioned air. Additionally, a stormwater system manages runoff from Regents Hall and the surrounding area (the building also has a planted roof), and its furniture includes tables and benches handcrafted from lumber harvested from the construction site.

WORLD

Pharmatech Associates Leads Design for First FDA-licensed Biomanufacturing Facility in China

Pharmatech Associates, a consultancy in the regulated life sciences industry, has been chosen by Pacific Biopharma Group (PBG) to provide the Basis of Design for the first FDA- and EMEA-approved biotechnology manufacturing facility ever built in China.

The Basis of Design for the 181,000 square foot facility will be the first reference document reviewed by the FDA as part of any licensure activity in China.

The new facility is a showcase cGMP laboratory that uses "single-use" technology throughout the biomanufacturing process. It is located in Taizhou, Jiangsu Province, in the emerging biomedical science park known as China Medical City (CMC).

CMC is considered to be one of the largest and most ambitious undertakings by any nation to establish biomedical capabilities for the development of novel therapies for the world marketplace.

The project is a joint venture between PBG and CMC. In addition to manufacturing biotechnology products for late-stage clinical supplies, the facility will be used for development projects borne at the California Institute for Quantitative Biosciences (QB3) whose lead campus is at University of California, San Francisco.

Portuguese Hovione to Acquire Pfizer’s Loughbeg Active Pharmaceutical Ingredients (API) Site in Ireland.

Hovione has agreed with Pfizer to acquire their Loughbeg Active Pharmaceutical Ingredients (API) site in Ireland. This site manufactures intermediates for Lipitor active pharmaceutical ingredient. The site has had a number of owners starting in 1984 with Angus Fine Chemicals, then Hickson & Welch, Warner Lambert, Pfizer and now Hovione. Over the last 10 years Pfizer has invested several hundred million dollars in plant and equipment there, making it a modern, well equipped site, meeting the highest standards in the industry. The deal is scheduled to be completed by early April 2009. Hovione Cork will employ 70-80 staff and will, over the next 24 months be transferring products from its Loures, Portugal site and validating processes for new compounds in expectation of drug approval. The terms of the transaction were not disclosed but Hovione will continue to provide manufacturing services for Pfizer.

"We made clinical trial materials for over 40 drug candidates last year. We have been investing heavily in R&D for over 6 years and now have a strong development pipe-line but have not invested in manufacturing assets since 2001, so it was time that we expanded our manufacturing capacity. This site offers everything that our Customers might want: large scale capacity, the highest standards, in a location where tax benefits are available to them and a well trained, innovative work-force" said Miguel Calado, CFO. The plant adds 4,594 sq. ft. (427m3) of capacity to Hovione's 8,715 sq. ft. (810m3) - of which 4,304 sq. ft. (400m3) are in Portugal and the remainder in China. The plant is multi-purpose and is able to address a large number of specialized chemistries such as hydrogenation and low temperature chemistry. The Cork site also provides Hovione with a new, EUR70m capability to produce spray-dried formulations. Hovione is the world's leading provider of GMP spray-drying services covering every scale (lab, pilot and several intermediate production scales) and is able to provide R&D support and commercial manufacturing.

Villax told the news outlet it would retain 70-80 of the 230-odd workers at the facility, while Pfizer issued a statement saying some of the plant’s staff may be moved to other company facilities. Over the next 24 months Hovione will transfer production of products to Cork from a site in Loures, Portugal.

At a time when most fine chemical producers are investing in Asia, Hovione is turning to Ireland. Cork has the highest concentration of API production anywhere in the world, with a vast and deep talent pool, with an excellent cGMP record with the health authorities since the mid-nineties. These sites belong to Large Pharma, companies that are now embracing outsourcing as a key part of their long-term manufacturing strategy. Hovione believes that having the right kind of capacity in Cork will help it better serve its Innovator customers when it comes to making APIs for their new product introductions. "We have been manufacturing in China for over 25 years - we know very well what China can do for the Pharma industry, but we also know what it can't do - and it is for those reasons that we are now in Cork" said Guy Villax, Chief Executive, "The Cork site, the New Jersey Technology Transfer Centre, Loures in Portugal and Taizhou and Macau in China now provide Hovione with the right range of capabilities in the correct geographies - every site meets FDA requirements for APIs but every site is suited to a different and well defined mission" he added.

Pharma manufacturing needs to become lean and cost-effective and this is always a challenge. The outsourcing business model gives manufacturers a head start, as contractors can provide their services to any Innovator company for any product and thus benefit from lower risk, better utilization of facilities and scale. In addition the contractor can select those compounds that have a good fit with its plant's technical capabilities; in turn the pharma company can avoid the expensive plant modifications often required to manufacture these compounds. It is this ability to produce for anyone that will contribute to making compounds fast and less expensively to the benefit of all stake-holders. However achieving this goal requires the ability to produce multiple small production campaigns -many simultaneously-, the skill to do rapid change-overs with validated cleaning, multi-purpose equipment design and lay-out that operate within a quality system specially designed for high levels of compliance yet of simple execution. This is what Hovione will be able to bring to the Cork site. "The combination of Hovione's 50 years of experience in API manufacture and contract manufacturing and the capabilities of the existing plant and compliance tradition of the Cork colleagues are a winning combination", said Noe Carreira, VP Manufacturing.

Hovione is an international group specializing in the development and compliant manufacture of active pharmaceutical ingredients, serving exclusively the pharmaceutical industry. With a 50-year track record, Hovione offers advanced technologies as well as APIs for all drug delivery systems, from oral to injectable and from inhalation to topical applications. With FDA inspected plants in Europe, the Far East and the US, Hovione is committed to the highest levels of service and quality. Specializing in complex chemistry and in particle engineering, Hovione offers all services related to the development, manufacture and pre-formulation of both new chemical entities (NCEs) and existing APIs for off-patent products.

MedImmune Leases New 100,000 sq ft Building at Cambridge, UK, Science Park

MedImmune has agreed to lease a new 100,000-square-foot research and development building at MEPC Granta Park in Cambridge, UK, the business and science campus reported on its blog.

MedImmune, which employs almost 400 people at its Cambridge site, is the largest tenant in the MEPC portfolio of eight business and science parks. Since a predecessor company, Cambridge Antibody Technology, moved into 20,000 square feet at the park in 2001, the company has expanded its presence there and now occupies 180,000 square feet.

Headquartered in Gaithersburg, Md., MedImmune is the global biologics unit of UK-based AstraZeneca. The building was named after and officially opened by Sir Aaron Klug, winner of the 1982 Nobel Prize in chemistry.

New Synthetic Biological Research Center in London

The UK will establish a new synthetic biology research center that will be a partnership between Imperial College London and the London School of Economics and Political Science.

The UK's Engineering and Physical Sciences Research Council has given an £8 million ($11.8 million) grant to start the Centre for Synthetic Biology and Innovation, which will focus on cell programming and other research areas.

The center will aim to conduct collaborations, generate intellectual property for licensing, and eventually generate spinout companies that “will play a part in spawning new industries for the UK,” Richard Kitney, who will direct the center, said in a statement.

Imperial College and LSE will work together to inform the public about research programs that will happen at the center through lectures and outreach about synthetic biology research. LSE also will train researchers in the ethical, legal, social, and political issues that surround the emerging field.

The center, which is part of the Imperial Institute for Systems and Synthetic Biology, will be based in the Faculty of Engineering, and it will work with the Department of Bioengineering and life sciences.

The funding will be used to establish the center’s physical space and for lab refurbishments, as well as recruiting academic staff and postdoctoral research fellows.

Paul Freemont, co-director of the center, said he expects that over the coming 20 to 50 years synthetic biology techniques will have the precision of electronics. “We want to get to the stage where we’ve got all the parts we need to build any biological machine that we want,” Freemont said.

Researchers initially will focus on developing standard systems and specifications to create such technologies, Freemont added.

“This will involve modifying DNA, inserting it into cells, and cataloguing what these cells do,” he explained. These technologies will be used “to assemble devices for use in a range of applications,” such as biological microprocessors, he said.

PPD Planning Expansion in Ireland and Singapore

PPD Inc is planning to set up new laboratory facilities in Ireland and Singapore to boost is capabilities in proving analytical services to customers.

The laboratory in Athlone, Ireland, will offer current Good Manufacturing Practice (cGMP) analytical testing services for clinical programmes spanning all phases of drug development. It will serve clients in Europe, the Middle East and Africa, and will create around 250 jobs, according to PPD.

The new lab represents an investment of around $18m by PPD, which will also receive some assistance from Ireland’s Investment and Development Agency (IDA).

It should start operations in the latter half of 2009, said the firm, and will concentrate on analytical testing services in method development and validation, stability and quality control testing.

Meanwhile, in Singapore PPD is expanding its central laboratory business with a new facility designed to meet “growing client demand in Southeast Asia.”

The new lab strengthens PPD’s presence in Singapore, where for a number of years the company has provided a range of clinical development services including clinical trial management and monitoring, patient recruitment, site identification and regulatory affairs.

The laboratory set-up in Singapore will be identical to PPD’s other central laboratories located in Brussels, Belgium; Kentucky in the US; and Beijing, China. PPD did not disclose the cost of the expansion.

PPD is one of the largest CROs in the sector, with a $5.1bn market cap that leaves it second only to Covance with a $6.1bn value. The company has seen some softening in its CRO business of late – marked by a slowdown in new business authorisations and a higher than usual cancellation rate – but has continued to invest for future growth.

A number of CROs have expanded their presence in Asia to serve both a growing customer base of Asian companies, as well as multinationals that are moving their clinical activities overseas to seek cost advantages and new pools of clinical trial subjects.

Clinical research in Asia Pacific grew more than 50 per cent from 2005 to 2006, according to CenterWatch. The region's population of 3.9 billion can help speed up patient enrolment in clinical trials, according to PPD.

Qatar Science & Technology Park, Biogem Sign Education/Research Agreement
Qatar Science & Technology Park and Biogem have signed an education and research agreement in which the Italian biotech consortium will train Qatar University students and perform joint research with the tech park on the pharmaceutical uses of desert plants and other topics.

In the first phase of the collaboration, graduate students from Qatar University will undertake a master’s program in biotechnology conducted by Biogem, in a program to commence in January 2009.
In the second phase joint research projects will be established between scientists in Italy and Qatar. Projects could include studying the pharmaceutical properties of plants indigenous to Qatar such as the Sidra tree (Ziziphus spina-christi). The projects will be principally funded by QSTP.

The Punjabi University Syndicate Approved Projects Worth Rs 23 crore to Be Completed at the University’s Campus at Talwandi Sabo.

These projects include construction of buildings for the departments of Biotechnology, Pharmaceutical and Drug Research, Computer Centre, IT Block, Library and a Religio-Cultural Centre.

The decisions were taken at the meeting of the Syndicate, chaired by Vice-Chancellor Jaspal Singh.

The Biomedical Innovation Platform (PTIB) Opens New Facilities at France's University Hospital

The Biomedical Innovation Platform (PTIB) at France's University Hospital of Bordeaux has launched a new biomarker research facility and plans in the coming year to open a next-generation sequencing center.

The new molecular core facility is the product of a partnership between the University Hospital of Bordeaux and the Regional Council of Aquitaine.

The facility is stocked with tools and technologies from Roche, Eurogentec, Beckman Coulter, Agencourt, DNAgenotek, and Biomek.

"Our first project will address mitochondrial DNA diversity and relationship with aging related diseases on a population of 3,000 patients and a selection of more than 250 mtSNP markers,” Patrick Merel, director of the molecular core facility, explained.

PTIB currently has four core facilities including a bioimaging laboratory; a molecular core lab; a histology, immunology, and cellular core lab; and an electrophysiology facility. It also hosts a biomaterial, medical device, and tissue-engineering working group, the Platelet Pathology National Reference Center, which is part of the French National Plan for Rare Diseases.

PTIB also serves as a biotechnology incubator that allows companies to share infrastructure and equipment.

MG America and MG2 in Italy Make Improvements Including Adding a Cleanroom

MG America and its parent company, MG2 of Bologna, Italy, leading suppliers of processing and packaging machinery to the pharmaceutical, cosmetic, nutritional, food and general packaging industries, have announced several recent developments, specifically designed to expand and improve the companies' service offerings within their core markets.

MG America has made a number of enhancements to their headquarters in Fairfield, NJ, including:

· A cleanroom for trial testing of customers' products on MG2 Capsule Fillers, demonstrations of new technologies and hands-on capsule filler training to augment classroom-based learning.

· A Packaging Showroom for equipment demonstrations and customer training.

· A newly redesigned lobby and conference area.

Personnel additions include a new technician to cover the Midwest region of the U.S. and a local salesperson exclusively focused on the pharmaceutical industry in Puerto Rico.

The world headquarters of MG2 in Bologna, Italy, is in the final stages of a major expansion, adding an additional 160,000 square feet to accommodate a new warehouse. The total investment for the construction and fully automated warehouse is estimated at a cost of $6,500,000.

In addition to capsule-filling machines and pouch filling machinery, MG America serves the end-of-line packaging needs of the pharmaceutical, cosmetic and food industries in the U.S., Canada and Puerto Rico. MG America operates from a 20,000 square foot facility in Fairfield, NJ. The in-house team of 20 employees provides the market with fully-staffed sales, service and parts departments. For more information, visit: www.mgamerica.com.

Brazil Gets Country's First Endangered Species Laboratory

Brazil's first Laboratory for Conservation of Endangered Species will be housed in the Federal University of Rio Grande do Norte (UFRN), in northern Brazil. The unit will be built and equipped with federal funds from the Studies and Projects Funding Body (Finep) and from the Bank of Northeastern Brazil (BNB).

The laboratory will be headed by Egyptian agronomist Magdi Ahmed Ibrahim Aloufa, Vegetable Physiology professor at the university.

Construction of the laboratory is at its final stages, with equipment about to be installed. According to Magdi Aloufa, when it is operating, the laboratory should be capable of accommodating in several 20-square-meter rooms (215 sq. ft.), some 200,000 saplings of plants native to the caatinga (a dry shrub land in northeastern Brazil), the Atlantic Forest and other biomes of the Northeast of Brazil, as is the case with pau Brasil (Brazil wood), angico, jurema and umbu.

"Apart from preserving biodiversity of forests and other Brazilian ecosystems, the main objective of the laboratory is to operate as a germplasm bank, supplying cloned and genetically improved plants to reforestation projects," explains Aloufa, who graduated from the University of Cairo.

The professor says that currently this kind of laboratory is used when the plan is to keep plants for use in the field, i.e., in nature itself.

"To conserve the same quantity we have in our little rooms it is necessary to have hundreds of hectares. Apart from that, these plants would be exposed to fires, plagues and the action of man," says the Egyptian, who arrived in Natal 24 years ago, married to a Brazilian teacher, after having finished his doctorate at the Pierre & Marie Curie University, in Paris.

Even before the laboratory is ready, Aloufa and his students started the process of collecting plants and saplings from fragments of the existing Atlantic Forest in the state of Rio Grande do Norte and in the caatinga, vegetation that is predominant in the state.

Apart from that, the laboratory already has agreements with universities in several other states in Brazil and in the Arab world, mainly in the United Arab Emirates and Bahrain. It is through this exchange that the laboratory should also conserve species turned to reforestation of savannah areas in the Gulf.

One of the pioneers in biotechnology and cloning of plant species of the Northeast, Magdi Aloufa also coordinated a project that developed date saplings adapted to the climate and earth of the Brazilian semiarid.

Betting on the extreme capacity of the plant that is native to the Middle East of adapting to degraded areas with little water, the researcher invested in the development of saplings capable of assuring the quality and speed of fruit generation.

The Egyptian's bet was based on the economic potential of the product and on the fact that most of the dates consumed in Brazil are imported from Mexico, the only country in Latin America where acclimatized dates are produced.

In Petrolina, in the interior of Pernambuco state, there are some date producers who planted the seeds, which does not guarantee the quality of the fruit.

"Apart from economic arguments, dates offer environmental advantages, as they are palms that fertilize the soil, lowering the temperature and interrupting the desertification process."

The agronomist also developed, with funds from the BNB, genetic improvement of cashew, which started being produced with quality control stemming from UFRN biotechnology laboratory research. Small farmers from the city of Serra do Mel, located 320 kilometers (199 miles) away from Natal, capital of Rio Grande do Norte, were benefited by the initiative.

"The city currently lives off cashew trade, but the fruit produced there grows natively, without quality guarantee," pointed out the agronomist.

Subsidiary of Stempeutics Opens Stem Cell Research Facility in Malaysia

Stempeutics Research Malaysia, a wholly-owned subsidiary of India’s Manipal Education and Medical Group, has opened a new RM 20 million ($5.7 million) stem cell research facility within Technology Park Malaysia.

Malaysia’s deputy minister of science, technology and innovation, YB Tuan Haji Fadilah Yusof, led dignitaries in opening what Malaysian officials said was their nation’s first stem cell research facility. He said Malaysia is looking to tap into a potential market for stem cell research and therapies pegged at $157 million, with an annual growth rate of 12 percent.

Malaysia is home to 80 biotechnology companies, 25 of which are owned at least in part by foreign investors. The companies specialize in agricultural biotechnology, healthcare and industrial biotechnology.

DNAVision Doubles its Lab and Office Space in Belgium

Belgian applied genetics and genomics services company DNAVision announced that it has doubled its laboratories and office space in Charleroi-Gosselies, Belgium, adding five new laboratory areas dedicated to cell culture and nucleic acid extraction.

The move is aimed at augmenting the company’s RNA- and DNA-based analytical techniques, expanding its biopharmaceutical services portfolio, and providing new GMP certified assays.

DNAVision said that its DNAVision AgriFood subsidiary, a spin-off of the University of Liège, will move to a new facility at the end of this month. Along with biosafety level 3 laboratory services, DNAVision said it will also provide a range of new services including next-generation sequencing, though it did not provide details on the sequencing platform it plans to use.

DNAVision CEO Jean-Pol Detiffe said that the firm’s revenues increased more than 50 percent in 2008. He also noted that the company plans to launch consumer genetic services this year.

DNAVision, a spin-out of the University of Brussels, has experience providing nucleic acid extraction and purification services. Most of these extraction services are accredited by the Belgian accreditation body BELAC.

DHL Global Forwarding Opens Life Science Competency Center in Carolina, Puerto Rico

DHL Global Forwarding has opened a Life Science Competency Center in Carolina, Puerto Rico, which will offer shipping services tailored to the needs of the island’s biotech and pharmaceutical companies.

The 70,000 sq ft facility is part of DHL’s range of Life Science Competency Centers that it has established at airports that have high traffic flows of life science products that require specialist handling.

DHL has established its life sciences centre’s in countries including Switzerland and Spain but the opening of the Puerto Rico site marks the first foray into North America.

The choice of Puerto Rico follows on from UPS setting up a 150,000 sq ft cold chain warehouse on the island, with the two delivery giants’ presence suggesting the local industry is in good health.

This has not always appeared to be the case in recent years, as concerns over quality control in Puerto Rico and a dip in companies need for small molecule manufacturing capacity affected employment.

However, Puerto Rico has promoted its biotech sector and this appears to be paying dividends. In addition the services offered by DHL and UPS may help to attract others to the island.

DHL will also use the site as a regional training centre for its other facilities dedicated to the warehousing and shipping of life science products.

The FDA Opens Office in Costa Rica

The FDA has established its first permanent presence in Latin America by opening an office in Costa Rica as part of “Beyond Our Borders Initiative”, which has also seen the agency set up three sites in China.

More US Food and Drug Administration (FDA) offices are scheduled to be set up in the region over the next 12 months, with Mexico and a South American country the likely sites.

These offices fit into the FDA’s “Beyond Our Borders Initiative” which the agency has launched in an attempt to more closely monitor standards in countries that have significant imports to the US.

Consequently China has been a primary focus of the initiative, with three FDA offices now set up in the country, but the agency has now turned its attention to Latin America.

Secretary Michael Leavitt, who leads the US Health and Human Services, said: “The countries of Central America, along with Panamá and the Dominican Republic, create the third-largest US export market in Latin America, and, every year, the United States imports millions of dollars in goods from these important trade partners.

“An HHS/FDA presence in the region will improve collaboration, strengthen our partnership and hasten the flow of quality goods to our markets.”

The establishment of an office in Costa Rica began in June 2008 when Leavitt met with Health Ministers from the region at a summit in the Central American country El Salvador.

Similar meetings may be taking place in the Middle East, which the FDA has identified as the next location it wants to establish itself in.

This follows on from a busy period for the agency, in which it has opened an office in Brussels to collaborate with the European Commission, set up at three sites in China and announced it will establishing a presence in two India cities.

Sandoz Expands its Mammalian Cell Culture Facility in Schaftenau, Austria

On November 14, 2008, Sandoz opened a new, fully integrated 13 000 L production line for innovative, cell culture derived biopharmaceuticals and antibodies in Schaftenau, Austria. The new line is an extension to an existing cell culture facility, which has been in operation since 2004.

The plant has a highly flexible, modular design and comprises one 100 L line utilized for development and technology transfer, one production line with a capacity of 3 000 L and - now - two independent 13 000 L lines. The fermentation units are operated in fed batch mode and are linked to fully equipped, separated downstream processing lines. All facilities are designed as multipurpose plants, thus enabling maximum flexibility in capacity utilization. The facilities have been designed in close contact with regulatory authorities and meet the latest cGMP requirements.

The investment emphasizes the strategic importance of biopharmaceutical products within Sandoz and Novartis, and will further strengthen the position of Sandoz as an internationally acknowledged cooperation partner in recombinant manufacturing.

Sandoz Biopharmaceuticals is one of two stand-alone global business units within the Sandoz Group. Sandoz has long been a biotechnological competence center within parent company Novartis, and has decades of experience in the development and production of biopharmaceutical products and active substances. It is also playing a pioneer role in the emerging market for biopharmaceuticals approved by the new biosimilar regulatory pathway.

Savipharm Facility Opens in Vietnam

A 21,520 sq. ft. (2,000 sq. m.) good manufacturing practice (GMP) compliant production facility has been inaugurated in Ho Chi Minh City, Vietnam.

The facility has been set up by Savipharm which will produce pills and effervescent tablets at the site. Savipharm’s facility represents a further expansion of Vietnam’s pharmaceutical industry, which consists of almost 100 GMP-ASEAN and GMP-WHO compliant production sites.

Protein Forest Opens UK Office

Protein Forest said that it has opened a European division headquartered in Newcastle upon Tyne, UK.

The Lexington, Mass.-based proteomics technologies firm said that the new European base will include office space and lab facilities to support sales, product demonstrations, applications development, and collaborative efforts with European partners.

The new UK office is led by European Business Director Robert Marchmont, who joined protein Forest from GE Healthcare. Russell Garlick, president and CEO of Protein Forest, said in a statement that Marchmont would be responsible for setting up dedicated sales and customer support teams and distribution networks within Europe.

Protein forest’s primary products include its ProteomeChip sample prep technology for mass spectrometry-based proteomics and bioinformatics products for mass spec experiments.

France's Biogemma to Use NimbleGen Sequence-Capture Arrays in Agbio Research

Biogemma, a Paris-based agricultural biotechnology company, announced that it will use Roche NimbleGen's sequence-capture technology in a research collaboration aimed at developing new technologies for its crop-breeding programs.

Biogemma will use recent optimizations of the technology with Roche 454's GS FLX Titanium sequencer to target unique genetic variations associated with genes that will be useful to crop breeders.

While the primary focus of Biogemma's relationship with Roche NimbleGen will be to co-design targeted sequence capture arrays for wheat and rapeseed studies, the French company eventually hopes to bring NimbleGen and 454 tools in house and to use the sequence-capture approach in other studies, according to a Biogemma official.

Nathalie Rivière, head of Biogemma's transcriptomics group, said the company decided to adopt the Roche NimbleGen approach to better understand two crops for which it sorely needs more information: wheat and rapeseed.

"These are the two species for which we really lack markers," Rivière said. "One of our shareholders' major needs is to have SNP information for wheat and rapeseed," she said. "These are [the] most complex species we work with because of their polyploidy."

Biogemma was founded in 1997 as a fusion of the biotechnology research endeavors of France's largest plant production groups: Chappes-based cooperative Limagrain; Pau-based cooperative Euralis; Rodez-based seed supplier RAGT; Paris-based agbio firm Sofiprotéal; and Paris-based agbio Unigrains.

Rivière said that Biogemma focuses its research on maize, wheat, rapeseed, and sunflower, and is divided into several research groups. It will be Biogemma's upstream genomics group, comprising a transcriptomics team and bioinformaticists, which will first use the sequence-capture method to study wheat and rapeseed.

"Our mission is to supply deliverables to our shareholders, and that means candidate genes, genetic markers, genetically modified plants, and also knowledge," Rivière said. "For this we have different technologies optimized by complementary R&D teams and we survey and incorporate new technologies to better fit our shareholders' needs and to increase our competitiveness."

According to Rivière, Biogemma has in the past procured expression arrays from Affymetrix, NimbleGen, and the University of Arizona, which in 2007 hosted the maize microarray project to develop a whole-genome maize array.

Rivière said Biogemma has also developed an expression array for rapeseed in collaboration with Affymetrix. To date most of the upstream genomics research has been in gene expression, rather than genotyping. The partnership with Roche Nimblegen represents a new commitment to move on to understanding genomic sequences with arrays, she said.

NimbleGen first developed the sequence-capture method together with Baylor College of Medicine researcher Richard Gibbs in 2007. The method enables customers to produce targeted, sequencing-ready samples in their lab using NimbleGen arrays. Samples are first hybridized to the arrays, which are designed to capture sequences for specific regions of the genome. The captured sequences are then released and ready for subsequent amplification and sequencing, according to the company.

When Roche acquired NimbleGen for $272.5 million in June 2007, officials for the Swiss drug and diagnostic giant said the company would sell the sequence-capture method for use with 454's technology, which they gained through their purchase of 454 earlier that year. Since then, Roche has developed relationships with researchers at Oxford University's Biomedical Research Centre, the Cancer Genomics Group at Barts and The London Medical School, and Baylor — all of which are using the NimbleGen-based sequence-capture method together with the 454 sequencer.

When it comes to Roche's sequence-capture approach, competitors include Agilent Technologies, which last June licensed a method from the Broad Institute that enables researchers to perform target capture in the liquid phase using oligo probes. The Broad's method, called genome partitioning, is based on hybridization to biotinylated baits.

While the method does not use arrays to perform sequence capture, it makes use of Agilent's microarray-fabrication infrastructure to design the probes and construct the oligo libraries. Fred Ernani, Agilent marketing manager for emerging genomic applications, said the company believes its genome-partitioning offering "addresses a substantial bottleneck in all [second]-generation-sequencing workflows, and thus will be widely adopted."

Rivière said that Biogemma chose NimbleGen over other approaches because it was "promising and attractive," and because Biogemma was encouraged by similar work it performed on the platform to study maize at Patrick Schnable's lab at the Center for Plant Genomics at Iowa State University.

CRO PFC Pharma Focus Partners with Blanchard y Asociados to Enter South American Markets

Switzerland-based CRO PFC Pharma Focus is entering the South American market through a partnership with Argentinean company Blanchard y Asociados.

The Swiss contract research organization (CRO) is hoping Blanchard y Asociados will facilitate its entry into the South American market by offering assistance with training and sharing its contacts with experts based in the region.

Entry into South America is the latest of PFC’s attempts to establish itself as a global presence, having previously opened offices or formed partnerships in Europe, the US and Asia.

Ran Frenkel, vice president of business development at PFC said: “PFC is very pleased with partnering with Blanchard & Asociados and with expanding our global presence. We believe that the South American market is an attractive region for our company. With our modular project management we can give our clients quick and cost-effective answers from crafting an effective proposal to successful study completion.

“Entering South America will enhance our abilities to give direct answers to the growing demands of our clients. It is important for us to maintain our high standards and core values and we believe we find an appropriate partner in Blanchard & Asociados.”

PFC will offer its clients in South America the same services that it provides to customers in other regions. These include clinical trial management and services such as monitoring, patient recruitment and regulatory affairs.

Japan to Support Academic Institutions with iPS Patenting

Japan's Education, Science, and Technology Ministry has decided to expand support for universities and research institutions wishing to patent technologies derived from studies on induced pluripotent stem cells.

Currently, only Kyoto University and selected institutions that research iPS cells receive ministry support, according to the report. Beginning in April, all universities and research institutions engaged in such work will be able to receive similar backing.

The support may help Japanese universities and research institutions hire intellectual property specialists that are well-versed in Western countries' patent systems, and conduct surveys of overseas stem cell patents, according to a report.

Morphotek Inks Evaluation Agreement with University Hospital Heidelberg

Morphotek, a subsidiary of Eisai Corporation of North America, said that it has signed an evaluation agreement with Germany's University Hospital Heidelberg and its technology transfer office in the area of therapeutic antibodies in oncology.

Terms of the agreement provide for Morphotek to provide an undisclosed research grant to the University Hospital/National Center for Tumor Diseases, and for Morphotek to use certain biological materials from the hospital to generate and validate therapeutic monoclonal antibodies against oncology targets selected by the company.

"This research program offers Morphotek unique clinical materials to generate and validate potential therapeutic antibodies using our Morphodoma technologies," Morphotek President and CEO Nicholas Nicolaides said in a statement.

Sanofi-Aventis to Sell Liquid Drug Manufacturing Plant in Colomiers, southwest France

Unither, which bought Sanofi’s Coutances plant in 2001, will continue to make several products at Colomiers on the latter’s behalf on a contractual basis, including the world leading cough syrup Rhinathiol (carbocistein).

A Sanofi spokesman told in-PharmaTechnologist that the firm’s decision was in response to a decline of the global market for liquid forms that has been going on for the last few years, rather than falling sales of any one particular drug produced at the site.

He explained that: “Most of the drugs [made at the facility] are moving to over-the-counter status and, as a result, are not likely to see dramatic growth in the future.”

The Sanofi representative added that the firm had decided to enter into the transaction and explained that it will be discussed at a consultation with the facility’s workforce, as is required by French law, at a meeting.

Amiens-headquartered Unither will maintain full production operations at the Colomiers plant and is expected to retain the facility’s 200-strong manufacturing workforce.

Despite these comments, the meeting may well be a difficult one for Sanofi given that its Colomiers employees were described as being “surprised” to learn of the sale in a report on the Ladepeche.fr news website.

Unither, which was set up by former Sanofi employees in 1993, currently has manufacturing facilities in Amiens, Bessay, Bordeaux, Gannat, Paris and Coutances at which it employees nearly 600 people.

Abbott Opens New Pharmaceutical Research Laboratory in Singapore

Abbott has announced the opening of a new pharmaceutical analytical research laboratory in Singapore's Biopolis research park. This new facility, Abbott's first pharmaceutical research and development site in Southeast Asia, will conduct stability studies, including studies on active pharmaceutical ingredients and novel formulations, to support global regulatory requirements for new pharmaceutical products. The work done at the laboratory will enable Abbott to accelerate the development of innovative investigational medicines and potentially deliver new treatments to patients faster in areas such as neuroscience and cancer. The opening was announced at a dedication and ribbon-cutting ceremony.

"Abbott has continually increased its investment in R&D over the last decade, resulting in a promising pipeline," said John M. Leonard, M.D., senior vice president, Pharmaceuticals, Research and Development, Abbott. "To realize the potential from the growth in Abbott's early stage pipeline requires the resources of a truly global R&D organization and the scientific talent available in Singapore made it a logical choice for Abbott's expansion in the region."

"We warmly welcome Abbott's expansion into pharmaceutical R&D from its established base in Singapore, which includes nutritional manufacturing and regional headquarters. This project fits well with our intent for Singapore to be an international biomedical sciences research cluster advancing human health. From its new laboratory at the Biopolis, Abbott will be able to access the extensive network of public and private sector researchers, academics and clinicians nearby," said Yeoh Keat Chuan, executive director, Biomedical Sciences, Singapore Economic Development Board.

Long known in Singapore for its nutritional products, Abbott is also building a nutrition manufacturing plant in Singapore, its largest nutritional investment ever. In addition, Abbott has expanded its presence in the country over the last few years with the launch of several key products, including HUMIRA(R) and the XIENCE V(TM) drug-eluting stent. Singapore is also home to regional headquarters offices for several Abbott businesses including nutrition, pharmaceuticals and diagnostics.

The Singapore laboratory is Abbott's latest global investment in facilities and resources to advance its pipeline. These initiatives include the Formulation Development Center that opened in Abbott Park, Ill., USA, in June 2008 and expansions at Abbott's drug delivery operations, SOLIQS, announced in Ludwigshafen, Germany in October 2008.

Joint Venture between CHA Biotech and Advanced Cell Technology to be called Stem Cell & Regenerative Medicine International

The joint venture between Advanced Cell Technology, Inc. and leading Korean-based biotechnology company CHA Biotech Co, Ltd. (CHA), announced that the company would be named “Stem Cell & Regenerative Medicine International.”

The partnership between Seoul-based CHA and Worcester, Massachusetts-based ACTC is an indication of the accelerating globalization of biotechnology, the company said. The formation of the new international joint venture to develop stem cell technologies based on ACTC’s proprietary hemangioblast cell technology was announced December 1.

Dr. Robert Lanza, head of ACTC’s retinal program and the joint venture’s Chief Scientific Advisor, said the new name captures the essence and scope of what the company is focused on in the most simple and obvious way.

The new company will be located in Worcester, MA and will focus on development of human blood cells and other clinical therapies. It is majority owned by CHA. ACTC will exclusively license all of its hemangioblast technology to the joint venture.

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